Please Share:: 
India Equity Research Reports, IPO and Stock News
Visit http://indiaer.blogspot.com/ for complete details �� ��
Month of litigation tangles…
In March we observed some important litigation issues, the most bizarre
being the law suit filed by US generic major Mylan against the USFDA
itself to block Ranbaxy’s Lipitor launch in November this year. Mylan’s
plea was to allow other generic players to launch Lipitor at the same
time, since Ranbaxy’s approval was from the troubled Paonta Sahib
facility. In another litigation issue, Wockhardt received some respite from
the Bombay High Court which stayed the petition for winding up brought
by some FCCB holders. In yet another litigation issue the Madras High
Court allowed an interim stay over the notification by the health ministry
which sought to ban 4 drugs including the widely used pain killer
Nimesulide on account of increasing health hazards.
In the domestic formulations market, after a long stint at the top level,
cough & cold drug Corex (Pfizer) lost its spot to Anti-infective Augmentin
(GSK Pharma) as per the latest modified methodology. On the pricing
front, the NPPA provided major relief to the top Insulin manufacturers by
allowing them to hike the Insulin prices by ~19% to accommodate raw
material cost increase.
On the exports front, Indian companies continued to receive incremental
product approvals from different regulators but other than normal
approvals there were peculiar cases such as Natco’s Anti-cancer drug
which received Orphan drug status from the USFDA, a first for any Indian
company. Strides received its 1st Anti-cancer approval from the EDQM.
Biocon’s partner Optimer received US patent for a diarrhea drug. On the
R&D front after a long gap Glenmark initiated studies on a Novel
Biological Entity (NBE) in the Anti-cancer space, taking its NBE count to
four. Also in the news was Aurobindo which got some support from
Pfizer to sort out USFDA issues for unit VI, but we observed some kneejerk
reaction on the stock price when Pfizer voluntarily recalled two
products from one lot supplied by Aurobindo for incorrect labeling.
Sector view
In March, the BSE Healthcare Index continued to underperform the
broader market on account of disappointing December numbers by
some bellwethers such as Ranbaxy, Cipla and to some extend Sun and
Dr Reddy’s. But for FY11 with ~13% YoY returns, the Healthcare sector
outperformed the broader market. We expect the Healthcare index to
outperform the broader market on account of good traction from the US,
Japan and other developed markets supported by product approvals,
growing presence in Pharmerging markets and strong foot-hold in India.
Regulatory approvals
Aurobindo receives final USFDA approval for HIV drug
Aurobindo Pharma has received final approval from the USFDA for
Famciclovir Tablets in 125mg, 250mg and 500mg strengths. Famciclovir
is the generic version of Novartis Pharmaceuticals Corp’s Famvir and is
indicated for the treatment of recurrent mucocutaneous herpes simplex
infections in HIV-infected patients and suppression of recurrent genital
herpes in immunocompetent patients. The product has a market size of
approximately US$ 175 million for the twelve months ending September
2010 according to IMS.
Aurobindo receives marketing authorisation for Insomnia drug from
UKMHRA
The UK Medicines and Healthcare products Regulatory Agency (UK
MHRA) has granted Aurobindo Pharma a marketing authorization of
Zolpidem Tartarate 5 mg tablets. It was originally developed and
marketed by the Sanofi Aventis under the brand name drug Ambien. It is
indicated for the treatment of insomnia (sleeping disorder). Ambien had
sales of Euro 441 million for the six months ended June 2010.
Aurobindo receives final USFDA approval for CNS drug
Aurobindo Pharma has received final approval from the USFDA to
manufacture and market Galantamine Tablets USP 4mg, 8mg and 12mg.
Galantamine is the generic version of Ortho McNeil Janssen
Pharmaceutical, Inc’s Razadyne Tablets. The product falls under the
neurological (CNS) therapeutic category and is indicated for the
treatment of mild to moderate dementia of the Alzheimer's type. The
product has a market size of approximately US$ 41 million for the twelve
months ending September 2010 according to IMS and will be launched
shortly.
Aurobindo receives final USFDA approval for CVS drug
Aurobindo Pharma has received final approval from the USFDA to
manufacture and market Fosinopril Sodium Tablets USP 10mg, 20mg
and 40mg. Fosinopril Sodium is the generic version of Bristol-Myers
Squibb’s Monopril. The product falls under the cardiovascular (CVS)
therapeutic category and is indicated for the treatment of hypertension.
The product has a market size of approximately US$ 20 million for the
twelve months ending September 2010 according to IMS and will be
launched shortly.
Biocon’s partner receives patent for Diarrhea drug
Biocon's drug development partner Optimer has received US patent for
drug Fidaxomicin. The drug is used to treat diarrhea and intestinal
diseases. Biocon expects to start the supply within a couple of months.
The closest competitor for Fidaxomicin is vancomycin - an antibiotic
injectable manufactured and supplied by Strides Arcolabs. The market
size is expected to be around US$ 350 million but the margins for
Biocon's drug could be bigger because Fidaxomicin is a novel product
while vancomycin is a generic one. The patent lease for Fidaxomicin is
expected to last till March 2027.
Cadila’s JV partner receives final USFDA approval for Cancer drug
Cadila Healthcare’s JV partner Hospira won approval from USFDA for
generic version of Sanofi-Aventis' cancer drug Taxotere. Taxotere had
sales of around US$ 1.2 billion in the US in 2010. The patent expires in
2012 and Hospira who has got approval for this from the USFDA is
expected to launch the drug Astrix possibly by the end of this month.
As per their agreement Cadila is expected to supply around 6 oncology
products to Hospira and this is one of them.
Glenmark receives final USFDA approval for Oral Contraceptive drug
Glenmark Generics, a subsidiary of Glenmark Pharmaceuticals has
received final approval from the USFDA for oral contraceptive
Norethindrone and Ethinyl Estradiol, USP 0.4 mg/0.035 mg tablets, the
generic version of Ovcon 35 tablets by Warner Chilcott, Inc. The product
will be marketed under the trade name Briellyn and distribution is
expected to start immediately. According to IMS Health for the 12 month
period ending December 2010, this combination achieved sales of US$
30 million.
Orchid receives tentative USFDA approval for Insomnia drug
Orchid Healthcare, a division of Orchid Chemicals & Pharmaceuticals
received tentative approval from the USFDA for Eszopiclone tablets in
the multiple strengths of 1 mg, 2 mg and 3 mg. It was originally
developed and marketed by Sepracor under the brand name of Lunesta.
The branded drug had annual sales of US$ 787 million for the 12 months
ended September 2010. Further, the patent is set to expire in 2014. The
drug indicated for the treatment of insomnia (sleeping disorder). Lupin,
Mylan, Glenmark generics have already received tentative approval form
US FDA.
Orchid receives marketing authorisation for migraine drug from
UKMHRA
Orchid Europe ltd, a subsidiary of Orchid Pharmaceuticals & Chemicals
has received marketing authorization for Naratriptan 2.5 mg tablets from
the UKMHRA. It was originally developed and marketed by the
GlaxoSmithkline under the brand name of Amerge. It is indicated for the
treatment of migraine.
Strides receives approval for Cancer drug from EDQM
Strides Arcolab has received approval from the European Directorate for
Quality Management (EDQMU) to sell generic Carboplatin used in the
treatment of ovarian cancer. Onco Therapies Ltd (OTL), the company’s
wholly-owned oncology subsidiary, has received approval from EU for
Carboplatin in the strength of 10 mg/ml in select European Union
countries. As per the latest data available from IMS, the combined
European market for Carboplatin stood at US$ 138 million.
New Manufacturing facility & Approvals
Jubilant to set up insecticide ingredient facility in Gujarat
Jubilant Life Sciences (JLS) is setting up a manufacturing plant to
produce Symtet, a key ingredient for making the world’s largest
insecticide Chlorpyrifos, at Bharuch in Gujarat, as part of its nearly | 350
crore capacity expansion plans for the next fiscal. JLS will set up a
manufacturing plant in the Special Economic Zone, at Bharuch, for the
chemical commercially known as Symtet/TCP, which will have a capacity
of 24,000 tonnes per annum (TPA). The new plant will also manufacture
chlorinated pyridine derivatives with an annual production of 5,000
tonnes. The facility, which is expected to be operational from the fourth
quarter of 2012, will make JLS the largest producer of Symtet globally
catering to more than 40% of the worldwide demand.
IPCA receives approval for Indore SEZ from UKMHRA
Ipca Laboratories formulations manufacturing unit at a special economic
zone in Indore has received the UKMHRA approval for good
manufacturing practices. It is the fourth manufacturing unit of the
company to have received approval from the UKMHRA. It expects to
receive USFDA approval the same facility in the next three months.
Domestic Market
Augmentin replaces Corex as the top selling Indian drug
In the | 55000 crore Indian domestic pharma market, Anti-infective
medicine Augmentin (till now the fifth largest selling drug) has replaced
cough and cold preparation Corex as the largest selling drug. Corex was
the leading drug for years. This is on account of change in the
methodology. The new sales analysis includes sales of the entire
organized retail market and the contribution made by hospitals and
doctors. In 2010, the sales of brand Augmentin was | 233 crore
compared to Corex brand sales of | 216 crore. Augmentin is brand of
GlaxoSmithKline while Corex is a brand of Pfizer. Corex sales have
slipped due to poor sales at hospitals. Under the new total sales audit
(TSA), sales by three trade channels-retail, hospitals and doctors-will be
tracked every month, as against the previous system when only the sales
by chemists were captured. Under the earlier system, the top five drugs
in 2010 were Corex (cough & cold), Human Mixtard (Anti-diabetic),
Voveran (Pain Killer), Phensedyl (cough & cold) and Augmentin (Antiinfective).
Madras HC stays ban notification on four products
The Madras High Court has allowed an interim stay on the notification of
the union health ministry (GSR 82 E) dated February 10, 2011 in which
the ministry had banned four of the most controversial drugs--- the nonsteroid
anti-inflammatory drug nimesulide (below 12 years age),
gastroprokinetic agent cisapride, decongestant, Phenylpropanolamine
(PPA) and human placenta extracts in the country with immediate effect.
Hearing a petition moved by Cipla on March 23, the court has stayed the
health ministry's notification. In a gazette notification dated February 10,
the ministry had banned these controversial drugs due to its adverse
effects on human health. Among these drugs, nimesulide was the most
controversial drug as even though it was banned in US, Britain, Canada,
Sweden, Denmark, Australia, New Zealand, Japan and other 168
countries, the drug was freely available in India, being aggressively
marketed by prominent drug companies.
NPPA hikes prices for Insulin brands
The National Pharmaceutical Pricing Authority (NPPA) increased the price
cap of locally-manufactured insulin brands by up to 18.5%. The drug
price regulator has allowed local Pharma companies Wockhardt and
Biocon to increase prices of their insulin brands. This follows a decision
by NPPA last December, raising the price cap on bulk drug or ingredients
used for making insulin by 16%. The regulator has allowed a marginally
higher increase in insulin price after factoring in rising conversion cost,
packing charges, process loss and packing material. At present, the two
Indian firms have a small share of the estimated | 250 crore insulin
market, with foreign drugmaker Danish company Novo Nordisk and US
company Eli Lilly dominating the market.
IP issues
Pfizer to help Aurobindo to sort out USFDA issues
Pfizer, which has a tie up with Aurobindo Pharma (APL) on generic
supplies, said it would extend support to the Indian company once it
understands the issues related to the USFDA import ban alert. Aurobindo
Pharma had recently found an import alert in USFDA Web site on
products manufactured at their Cephalosporin facility, Unit VI at Chitkul
Village near Hyderabad.
Gilead, Roche sue Natco Pharma for Tamiflu
Gilead Sciences, along with its partner Roche, has sued Natco Pharma
for infringing the patents of its blockbuster bird flu drug Tamiflu
(oseltamivir phosphate). The drug is believed to have clocked US$1
billion in sales in the US last year. Gilead is the innovator of the drug,
whereas Roche markets it by paying royalty to the innovator. Natco is
claiming the first to file status in generic Tamiflu. The company has filed
an abbreviated new drug application (ANDA) with the US FDA in
February 2011.
Mylan sues USFDA for Lipitor
Mylan Inc sued the USFDA, seeking to block Ranbaxy Laboratories’
exclusive rights to sell a generic version of Pfizer Inc.’s cholesterol pill
Lipitor, the world’s best- selling medicine. In a complaint filed March 18
in federal court in Washington, Mylan said it and other generic-drug
makers should be allowed to enter the market as soon as a patent
expires. Ranbaxy reached an agreement with Pfizer in 2008 to sell copies
of the medicine beginning in November. It has not yet received the final
regulatory approval on its application to sell the drug. In its complaint,
Mylan contends that Ranbaxy isn’t eligible for that marketing exclusivity
because of “false and unreliable data” from its manufacturing site in
Paonta Sahib, where the Lipitor generic would be produced.
Product Launches
Dr Reddy’s launches Xyzal in the US
Dr Reddy's Laboratories has launched Levocetirizine tablets in 5 mg
strengths in the US. The drug is the generic version of UCB Inc's Xyzal
tablets. The USFDA had approved the company's Abbreviation New Drug
Application (ANDA) for Levocetirizine tablets on 24 February 2011. As
per IMS Health, the drug had total annual sales of approximately US$ 238
million in the US during 12 months ended September 2010.
M & As and demerger
Dr Reddy’s completes acquisition of GSK’s US facility
Dr Reddy's Laboratories (DRL) has completed the acquisition of
GlaxoSmithKline's US oral penicillin facility and product portfolio
pursuant to the agreement signed and announced by the companies on
November 23, 2010. As a result of the acquisition, DRL assumes the
ownership of the penicillin manufacturing site in Bristol, Tennessee, US,
and rights for the Augmentin and Amoxil brands in the US. GSK will
retain the existing rights for these brands outside the US. Financial terms
and conditions of the transaction have not being disclosed.
R&D developments
Glenmark announces discovery of new molecule
Glenmark Pharmaceuticals announced the discovery of a new molecule
for oncology treatment and it expects to file an application for phase-I
trials in the fourth quarter of FY12. Developed at Glenmark's Switzerlandbased
research centre, the GBR 401 molecule is an anti-CD19
monoclonal antibody primarily targeted for treating lymphoma and
leukemia of B-cell origin. In addition, the molecule also has potential to
treat disorders like rheumatoid arthritis. The molecule is in the same
segment of anti-cancer biotech product rituximab, which had annual
global sales of US$ 6 billion.
Natco drug gets Orphan drug status in US
Natco Pharma has received 'Orphan Drug Designation' for its novel anticancer
drug (NRC-AN-019) from the USFDA. This is for three indications
– Glioma (brain tumour), pancreatic cancer and chronic myelogenous
leukaemia. It is for the first time that an Indian company's drug is
designated an 'Orphan' drug by the USFDA. Orphan drug designation is
given by USFDA for rare diseases that affect less than 2 lakh patients in
the USA. Since the market for drugs intended to treat rare diseases is
small, USFDA extends special incentives to companies involved in the
discovery and development of such drugs. These incentives include a
seven year marketing exclusivity, specific tax credits and waiver of
prescription drug user fees (which is about $1.5 million per indication)
Special grants and benefits to defray the costs of clinical research on
these drugs may also be extended by US FDA. Natco is close to
completing the phase I clinical trial of NRC-AN-019 in India and planning
to take the drug forward for further clinical trials in USA and other
countries in addition to India.
Deals & Alliances
Indoco extends Watson tie-up
Indoco Remedies is in talks to extend its tie-up with Watson
Pharmaceuticals Inc to cover four to five more products in the US.
Indoco and Watson Pharmaceuticals have a cost and profit sharing
partnership to launch sterile products in the US market. Indoco has so far
filed five products for the USFDA approval (with Watson) while the
remaining five would be filed in the coming months.
Ranbaxy to sale Daiichi products in Singapore
Daiichi Sankyo and Ranbaxy Laboratories have announced the start of
synergistic initiative to leverage Ranbaxy’s presence in Singapore to
market products originally discovered by Daiichi Sankyo. Ranbaxy will
market four products of Daiichi Sankyo origin, including Cravit
(levofloxacin) tab and Cravit IV in Singapore. Levofloxacin is a synthetic
antibacterial agent of the fluoroquinolone class that is used to treat a
broad range of infections.
Product Recalls
Pfizer recalls two Aurobindo products for labeling revision
Pfizer Inc’s wholly-owned arm Greenstone LLC is conducting a voluntary
recall in the US market of two drugs, which were contract manufactured
by Aurobindo Pharma due to labeling error. The recall involves
Citalopram 10mg tablets (100-count bottle), used in treatment of
depression and Finasteride 5mg tablets (90-count bottle) prescribed for
treating prostrate enlargement. Around 500 bottles of Finasteride have
been labeled as Citalopram. Aurobindo has maintained that there will not
be negative impact on account of these recalls.
Other developments
Alembic gets IT notice for extra taxes
Alembic will have to shell out | 20 crore in taxes before the end of the
current financial year towards clearing past dues and liabilities, said
income tax department officials. The company has already paid | 8.5
crore so far. The income tax (I-T) survey at the company has revealed
that the company reallocated certain expenses between their tax-exempt
unit at Himachal Pradesh and its Vadodara unit. The survey went on for
14 days at the company's headquarters on Gorwa Road.
Dr Reddy’s to issue bonus debentures
Dr Reddy's Laboratories will issue bonus debentures to its shareholders
worth up to | 520 crore. The company said its shareholders are entitled
to receive six unsecured redeemable non convertible bonus debentures
of | 5 each for every existing fully paid equity share of | 5 each. The
tenor of the bonus debentures will be 36 months from the date of
allotment and they would be redeemable at par in full at the end of the
period. The board has also fixed 9.25% as the coupon rate on these
debentures, payable annually. The company said it plans to list the
bonus debentures on both NSE and BSE.
Accident at Dr Reddy’s facility kills two workers
Two labourers were burnt to death in a fire at the Dr Reddy's
Laboratories (DRL)' plant near Hyderabad. The fire broke out in a lift in
the unit-II of the plant at Bollarum. This is the second incident at the
pharma major's plant in the past three months. Two DRL employees
were killed due to gas leak in the first mishap in December last.
Elder Pharma to raise funds through bond issue
Elder Pharmaceuticals plans to raise | 105 crore through seven -year
bonds at 11.25%. The bonds feature repayment in 10 equal semi-annual
installments commencing two years after the issue date. Proceeds from
these bonds will refinance existing higher cost debt.
Bombay HC stays winding up petition against Wockhardt
The Bombay High Court has granted interim relief to Wockhardt by
staying the admission of a winding-up petition filed by some FCCB
holders. The court has also asked Wockhardt to deposit | 115 crore
rupees by May 3. On March 11, the HC had admitted a winding up
petition against the company filed by these FCCB holders. Wockhardt
had appealed against the order. Saddled with a debt of about | 3700
crore, Wockhardt had defaulted on its FCCB repayment and gone in for a
corporate debt restructuring (CDR) process last year. The FCCB holders
include Singapore-based hedge fund QVT Financial LP and an overseas
unit of Sun Pharmaceutical industries. These bondholders had earlier
rejected a fresh settlement proposal and had been pressing ahead with a
winding-up petition.
Alembic fixes record date for Scheme of Arrangement
Alembic has fixed April 14 2011 as record date to ascertain the eligibility
of the shareholders of Alembic to receive the equity shares of Alembic
Pharmaceuticals. The Equity shareholders of Alembic will be allotted 1
equity share (face value of |2) of Alembic Pharmaceuticals for every one
equity share held in the Alembic.
India Equity Research Reports, IPO and Stock News
Visit http://indiaer.blogspot.com/ for complete details �� ��
Month of litigation tangles…
In March we observed some important litigation issues, the most bizarre
being the law suit filed by US generic major Mylan against the USFDA
itself to block Ranbaxy’s Lipitor launch in November this year. Mylan’s
plea was to allow other generic players to launch Lipitor at the same
time, since Ranbaxy’s approval was from the troubled Paonta Sahib
facility. In another litigation issue, Wockhardt received some respite from
the Bombay High Court which stayed the petition for winding up brought
by some FCCB holders. In yet another litigation issue the Madras High
Court allowed an interim stay over the notification by the health ministry
which sought to ban 4 drugs including the widely used pain killer
Nimesulide on account of increasing health hazards.
In the domestic formulations market, after a long stint at the top level,
cough & cold drug Corex (Pfizer) lost its spot to Anti-infective Augmentin
(GSK Pharma) as per the latest modified methodology. On the pricing
front, the NPPA provided major relief to the top Insulin manufacturers by
allowing them to hike the Insulin prices by ~19% to accommodate raw
material cost increase.
On the exports front, Indian companies continued to receive incremental
product approvals from different regulators but other than normal
approvals there were peculiar cases such as Natco’s Anti-cancer drug
which received Orphan drug status from the USFDA, a first for any Indian
company. Strides received its 1st Anti-cancer approval from the EDQM.
Biocon’s partner Optimer received US patent for a diarrhea drug. On the
R&D front after a long gap Glenmark initiated studies on a Novel
Biological Entity (NBE) in the Anti-cancer space, taking its NBE count to
four. Also in the news was Aurobindo which got some support from
Pfizer to sort out USFDA issues for unit VI, but we observed some kneejerk
reaction on the stock price when Pfizer voluntarily recalled two
products from one lot supplied by Aurobindo for incorrect labeling.
Sector view
In March, the BSE Healthcare Index continued to underperform the
broader market on account of disappointing December numbers by
some bellwethers such as Ranbaxy, Cipla and to some extend Sun and
Dr Reddy’s. But for FY11 with ~13% YoY returns, the Healthcare sector
outperformed the broader market. We expect the Healthcare index to
outperform the broader market on account of good traction from the US,
Japan and other developed markets supported by product approvals,
growing presence in Pharmerging markets and strong foot-hold in India.
Regulatory approvals
Aurobindo receives final USFDA approval for HIV drug
Aurobindo Pharma has received final approval from the USFDA for
Famciclovir Tablets in 125mg, 250mg and 500mg strengths. Famciclovir
is the generic version of Novartis Pharmaceuticals Corp’s Famvir and is
indicated for the treatment of recurrent mucocutaneous herpes simplex
infections in HIV-infected patients and suppression of recurrent genital
herpes in immunocompetent patients. The product has a market size of
approximately US$ 175 million for the twelve months ending September
2010 according to IMS.
Aurobindo receives marketing authorisation for Insomnia drug from
UKMHRA
The UK Medicines and Healthcare products Regulatory Agency (UK
MHRA) has granted Aurobindo Pharma a marketing authorization of
Zolpidem Tartarate 5 mg tablets. It was originally developed and
marketed by the Sanofi Aventis under the brand name drug Ambien. It is
indicated for the treatment of insomnia (sleeping disorder). Ambien had
sales of Euro 441 million for the six months ended June 2010.
Aurobindo receives final USFDA approval for CNS drug
Aurobindo Pharma has received final approval from the USFDA to
manufacture and market Galantamine Tablets USP 4mg, 8mg and 12mg.
Galantamine is the generic version of Ortho McNeil Janssen
Pharmaceutical, Inc’s Razadyne Tablets. The product falls under the
neurological (CNS) therapeutic category and is indicated for the
treatment of mild to moderate dementia of the Alzheimer's type. The
product has a market size of approximately US$ 41 million for the twelve
months ending September 2010 according to IMS and will be launched
shortly.
Aurobindo receives final USFDA approval for CVS drug
Aurobindo Pharma has received final approval from the USFDA to
manufacture and market Fosinopril Sodium Tablets USP 10mg, 20mg
and 40mg. Fosinopril Sodium is the generic version of Bristol-Myers
Squibb’s Monopril. The product falls under the cardiovascular (CVS)
therapeutic category and is indicated for the treatment of hypertension.
The product has a market size of approximately US$ 20 million for the
twelve months ending September 2010 according to IMS and will be
launched shortly.
Biocon’s partner receives patent for Diarrhea drug
Biocon's drug development partner Optimer has received US patent for
drug Fidaxomicin. The drug is used to treat diarrhea and intestinal
diseases. Biocon expects to start the supply within a couple of months.
The closest competitor for Fidaxomicin is vancomycin - an antibiotic
injectable manufactured and supplied by Strides Arcolabs. The market
size is expected to be around US$ 350 million but the margins for
Biocon's drug could be bigger because Fidaxomicin is a novel product
while vancomycin is a generic one. The patent lease for Fidaxomicin is
expected to last till March 2027.
Cadila’s JV partner receives final USFDA approval for Cancer drug
Cadila Healthcare’s JV partner Hospira won approval from USFDA for
generic version of Sanofi-Aventis' cancer drug Taxotere. Taxotere had
sales of around US$ 1.2 billion in the US in 2010. The patent expires in
2012 and Hospira who has got approval for this from the USFDA is
expected to launch the drug Astrix possibly by the end of this month.
As per their agreement Cadila is expected to supply around 6 oncology
products to Hospira and this is one of them.
Glenmark receives final USFDA approval for Oral Contraceptive drug
Glenmark Generics, a subsidiary of Glenmark Pharmaceuticals has
received final approval from the USFDA for oral contraceptive
Norethindrone and Ethinyl Estradiol, USP 0.4 mg/0.035 mg tablets, the
generic version of Ovcon 35 tablets by Warner Chilcott, Inc. The product
will be marketed under the trade name Briellyn and distribution is
expected to start immediately. According to IMS Health for the 12 month
period ending December 2010, this combination achieved sales of US$
30 million.
Orchid receives tentative USFDA approval for Insomnia drug
Orchid Healthcare, a division of Orchid Chemicals & Pharmaceuticals
received tentative approval from the USFDA for Eszopiclone tablets in
the multiple strengths of 1 mg, 2 mg and 3 mg. It was originally
developed and marketed by Sepracor under the brand name of Lunesta.
The branded drug had annual sales of US$ 787 million for the 12 months
ended September 2010. Further, the patent is set to expire in 2014. The
drug indicated for the treatment of insomnia (sleeping disorder). Lupin,
Mylan, Glenmark generics have already received tentative approval form
US FDA.
Orchid receives marketing authorisation for migraine drug from
UKMHRA
Orchid Europe ltd, a subsidiary of Orchid Pharmaceuticals & Chemicals
has received marketing authorization for Naratriptan 2.5 mg tablets from
the UKMHRA. It was originally developed and marketed by the
GlaxoSmithkline under the brand name of Amerge. It is indicated for the
treatment of migraine.
Strides receives approval for Cancer drug from EDQM
Strides Arcolab has received approval from the European Directorate for
Quality Management (EDQMU) to sell generic Carboplatin used in the
treatment of ovarian cancer. Onco Therapies Ltd (OTL), the company’s
wholly-owned oncology subsidiary, has received approval from EU for
Carboplatin in the strength of 10 mg/ml in select European Union
countries. As per the latest data available from IMS, the combined
European market for Carboplatin stood at US$ 138 million.
New Manufacturing facility & Approvals
Jubilant to set up insecticide ingredient facility in Gujarat
Jubilant Life Sciences (JLS) is setting up a manufacturing plant to
produce Symtet, a key ingredient for making the world’s largest
insecticide Chlorpyrifos, at Bharuch in Gujarat, as part of its nearly | 350
crore capacity expansion plans for the next fiscal. JLS will set up a
manufacturing plant in the Special Economic Zone, at Bharuch, for the
chemical commercially known as Symtet/TCP, which will have a capacity
of 24,000 tonnes per annum (TPA). The new plant will also manufacture
chlorinated pyridine derivatives with an annual production of 5,000
tonnes. The facility, which is expected to be operational from the fourth
quarter of 2012, will make JLS the largest producer of Symtet globally
catering to more than 40% of the worldwide demand.
IPCA receives approval for Indore SEZ from UKMHRA
Ipca Laboratories formulations manufacturing unit at a special economic
zone in Indore has received the UKMHRA approval for good
manufacturing practices. It is the fourth manufacturing unit of the
company to have received approval from the UKMHRA. It expects to
receive USFDA approval the same facility in the next three months.
Domestic Market
Augmentin replaces Corex as the top selling Indian drug
In the | 55000 crore Indian domestic pharma market, Anti-infective
medicine Augmentin (till now the fifth largest selling drug) has replaced
cough and cold preparation Corex as the largest selling drug. Corex was
the leading drug for years. This is on account of change in the
methodology. The new sales analysis includes sales of the entire
organized retail market and the contribution made by hospitals and
doctors. In 2010, the sales of brand Augmentin was | 233 crore
compared to Corex brand sales of | 216 crore. Augmentin is brand of
GlaxoSmithKline while Corex is a brand of Pfizer. Corex sales have
slipped due to poor sales at hospitals. Under the new total sales audit
(TSA), sales by three trade channels-retail, hospitals and doctors-will be
tracked every month, as against the previous system when only the sales
by chemists were captured. Under the earlier system, the top five drugs
in 2010 were Corex (cough & cold), Human Mixtard (Anti-diabetic),
Voveran (Pain Killer), Phensedyl (cough & cold) and Augmentin (Antiinfective).
Madras HC stays ban notification on four products
The Madras High Court has allowed an interim stay on the notification of
the union health ministry (GSR 82 E) dated February 10, 2011 in which
the ministry had banned four of the most controversial drugs--- the nonsteroid
anti-inflammatory drug nimesulide (below 12 years age),
gastroprokinetic agent cisapride, decongestant, Phenylpropanolamine
(PPA) and human placenta extracts in the country with immediate effect.
Hearing a petition moved by Cipla on March 23, the court has stayed the
health ministry's notification. In a gazette notification dated February 10,
the ministry had banned these controversial drugs due to its adverse
effects on human health. Among these drugs, nimesulide was the most
controversial drug as even though it was banned in US, Britain, Canada,
Sweden, Denmark, Australia, New Zealand, Japan and other 168
countries, the drug was freely available in India, being aggressively
marketed by prominent drug companies.
NPPA hikes prices for Insulin brands
The National Pharmaceutical Pricing Authority (NPPA) increased the price
cap of locally-manufactured insulin brands by up to 18.5%. The drug
price regulator has allowed local Pharma companies Wockhardt and
Biocon to increase prices of their insulin brands. This follows a decision
by NPPA last December, raising the price cap on bulk drug or ingredients
used for making insulin by 16%. The regulator has allowed a marginally
higher increase in insulin price after factoring in rising conversion cost,
packing charges, process loss and packing material. At present, the two
Indian firms have a small share of the estimated | 250 crore insulin
market, with foreign drugmaker Danish company Novo Nordisk and US
company Eli Lilly dominating the market.
IP issues
Pfizer to help Aurobindo to sort out USFDA issues
Pfizer, which has a tie up with Aurobindo Pharma (APL) on generic
supplies, said it would extend support to the Indian company once it
understands the issues related to the USFDA import ban alert. Aurobindo
Pharma had recently found an import alert in USFDA Web site on
products manufactured at their Cephalosporin facility, Unit VI at Chitkul
Village near Hyderabad.
Gilead, Roche sue Natco Pharma for Tamiflu
Gilead Sciences, along with its partner Roche, has sued Natco Pharma
for infringing the patents of its blockbuster bird flu drug Tamiflu
(oseltamivir phosphate). The drug is believed to have clocked US$1
billion in sales in the US last year. Gilead is the innovator of the drug,
whereas Roche markets it by paying royalty to the innovator. Natco is
claiming the first to file status in generic Tamiflu. The company has filed
an abbreviated new drug application (ANDA) with the US FDA in
February 2011.
Mylan sues USFDA for Lipitor
Mylan Inc sued the USFDA, seeking to block Ranbaxy Laboratories’
exclusive rights to sell a generic version of Pfizer Inc.’s cholesterol pill
Lipitor, the world’s best- selling medicine. In a complaint filed March 18
in federal court in Washington, Mylan said it and other generic-drug
makers should be allowed to enter the market as soon as a patent
expires. Ranbaxy reached an agreement with Pfizer in 2008 to sell copies
of the medicine beginning in November. It has not yet received the final
regulatory approval on its application to sell the drug. In its complaint,
Mylan contends that Ranbaxy isn’t eligible for that marketing exclusivity
because of “false and unreliable data” from its manufacturing site in
Paonta Sahib, where the Lipitor generic would be produced.
Product Launches
Dr Reddy’s launches Xyzal in the US
Dr Reddy's Laboratories has launched Levocetirizine tablets in 5 mg
strengths in the US. The drug is the generic version of UCB Inc's Xyzal
tablets. The USFDA had approved the company's Abbreviation New Drug
Application (ANDA) for Levocetirizine tablets on 24 February 2011. As
per IMS Health, the drug had total annual sales of approximately US$ 238
million in the US during 12 months ended September 2010.
M & As and demerger
Dr Reddy’s completes acquisition of GSK’s US facility
Dr Reddy's Laboratories (DRL) has completed the acquisition of
GlaxoSmithKline's US oral penicillin facility and product portfolio
pursuant to the agreement signed and announced by the companies on
November 23, 2010. As a result of the acquisition, DRL assumes the
ownership of the penicillin manufacturing site in Bristol, Tennessee, US,
and rights for the Augmentin and Amoxil brands in the US. GSK will
retain the existing rights for these brands outside the US. Financial terms
and conditions of the transaction have not being disclosed.
R&D developments
Glenmark announces discovery of new molecule
Glenmark Pharmaceuticals announced the discovery of a new molecule
for oncology treatment and it expects to file an application for phase-I
trials in the fourth quarter of FY12. Developed at Glenmark's Switzerlandbased
research centre, the GBR 401 molecule is an anti-CD19
monoclonal antibody primarily targeted for treating lymphoma and
leukemia of B-cell origin. In addition, the molecule also has potential to
treat disorders like rheumatoid arthritis. The molecule is in the same
segment of anti-cancer biotech product rituximab, which had annual
global sales of US$ 6 billion.
Natco drug gets Orphan drug status in US
Natco Pharma has received 'Orphan Drug Designation' for its novel anticancer
drug (NRC-AN-019) from the USFDA. This is for three indications
– Glioma (brain tumour), pancreatic cancer and chronic myelogenous
leukaemia. It is for the first time that an Indian company's drug is
designated an 'Orphan' drug by the USFDA. Orphan drug designation is
given by USFDA for rare diseases that affect less than 2 lakh patients in
the USA. Since the market for drugs intended to treat rare diseases is
small, USFDA extends special incentives to companies involved in the
discovery and development of such drugs. These incentives include a
seven year marketing exclusivity, specific tax credits and waiver of
prescription drug user fees (which is about $1.5 million per indication)
Special grants and benefits to defray the costs of clinical research on
these drugs may also be extended by US FDA. Natco is close to
completing the phase I clinical trial of NRC-AN-019 in India and planning
to take the drug forward for further clinical trials in USA and other
countries in addition to India.
Deals & Alliances
Indoco extends Watson tie-up
Indoco Remedies is in talks to extend its tie-up with Watson
Pharmaceuticals Inc to cover four to five more products in the US.
Indoco and Watson Pharmaceuticals have a cost and profit sharing
partnership to launch sterile products in the US market. Indoco has so far
filed five products for the USFDA approval (with Watson) while the
remaining five would be filed in the coming months.
Ranbaxy to sale Daiichi products in Singapore
Daiichi Sankyo and Ranbaxy Laboratories have announced the start of
synergistic initiative to leverage Ranbaxy’s presence in Singapore to
market products originally discovered by Daiichi Sankyo. Ranbaxy will
market four products of Daiichi Sankyo origin, including Cravit
(levofloxacin) tab and Cravit IV in Singapore. Levofloxacin is a synthetic
antibacterial agent of the fluoroquinolone class that is used to treat a
broad range of infections.
Product Recalls
Pfizer recalls two Aurobindo products for labeling revision
Pfizer Inc’s wholly-owned arm Greenstone LLC is conducting a voluntary
recall in the US market of two drugs, which were contract manufactured
by Aurobindo Pharma due to labeling error. The recall involves
Citalopram 10mg tablets (100-count bottle), used in treatment of
depression and Finasteride 5mg tablets (90-count bottle) prescribed for
treating prostrate enlargement. Around 500 bottles of Finasteride have
been labeled as Citalopram. Aurobindo has maintained that there will not
be negative impact on account of these recalls.
Other developments
Alembic gets IT notice for extra taxes
Alembic will have to shell out | 20 crore in taxes before the end of the
current financial year towards clearing past dues and liabilities, said
income tax department officials. The company has already paid | 8.5
crore so far. The income tax (I-T) survey at the company has revealed
that the company reallocated certain expenses between their tax-exempt
unit at Himachal Pradesh and its Vadodara unit. The survey went on for
14 days at the company's headquarters on Gorwa Road.
Dr Reddy’s to issue bonus debentures
Dr Reddy's Laboratories will issue bonus debentures to its shareholders
worth up to | 520 crore. The company said its shareholders are entitled
to receive six unsecured redeemable non convertible bonus debentures
of | 5 each for every existing fully paid equity share of | 5 each. The
tenor of the bonus debentures will be 36 months from the date of
allotment and they would be redeemable at par in full at the end of the
period. The board has also fixed 9.25% as the coupon rate on these
debentures, payable annually. The company said it plans to list the
bonus debentures on both NSE and BSE.
Accident at Dr Reddy’s facility kills two workers
Two labourers were burnt to death in a fire at the Dr Reddy's
Laboratories (DRL)' plant near Hyderabad. The fire broke out in a lift in
the unit-II of the plant at Bollarum. This is the second incident at the
pharma major's plant in the past three months. Two DRL employees
were killed due to gas leak in the first mishap in December last.
Elder Pharma to raise funds through bond issue
Elder Pharmaceuticals plans to raise | 105 crore through seven -year
bonds at 11.25%. The bonds feature repayment in 10 equal semi-annual
installments commencing two years after the issue date. Proceeds from
these bonds will refinance existing higher cost debt.
Bombay HC stays winding up petition against Wockhardt
The Bombay High Court has granted interim relief to Wockhardt by
staying the admission of a winding-up petition filed by some FCCB
holders. The court has also asked Wockhardt to deposit | 115 crore
rupees by May 3. On March 11, the HC had admitted a winding up
petition against the company filed by these FCCB holders. Wockhardt
had appealed against the order. Saddled with a debt of about | 3700
crore, Wockhardt had defaulted on its FCCB repayment and gone in for a
corporate debt restructuring (CDR) process last year. The FCCB holders
include Singapore-based hedge fund QVT Financial LP and an overseas
unit of Sun Pharmaceutical industries. These bondholders had earlier
rejected a fresh settlement proposal and had been pressing ahead with a
winding-up petition.
Alembic fixes record date for Scheme of Arrangement
Alembic has fixed April 14 2011 as record date to ascertain the eligibility
of the shareholders of Alembic to receive the equity shares of Alembic
Pharmaceuticals. The Equity shareholders of Alembic will be allotted 1
equity share (face value of |2) of Alembic Pharmaceuticals for every one
equity share held in the Alembic.
No comments:
Post a Comment