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Pharma Monthly
Regulatory approvals
Dr Reddy's to launch anti-asthma tablets in US market
Dr Reddy's Laboratories received approval from the US Food and Drug
Administration (USFDA) to launch generic Zafirlukast tablets. The drug is
used for treating asthma. The approval by the USFDA for its abbreviated
new drug application (ANDA) for Zafirlukast tablets follows a favourable
court judgment in the patent infringement case filed against it by patent
holder AstraZeneca. According to IMS health, Zafirlukast tablets had total
sales of around US$50 million in the US market for 12 months ended
August 31, 2010.
Sun Pharma gets tentative FDA nod for generic Cymbalta
Sun Pharmaceuticals has received tentative approval from the USFDA to
market the generic version of Eli Lilly & Co's Cymbalta in the US market.
Cymbalta is used in the treatment of major depressive disorder,
generalised anxiety disorder and diabetic peripheral neuropathic pain.
Cymbalta has annual sales of about US$3 billion in the US market.
Lupin gets USFDA nod for Suprax chewable tablets
Lupin’s US subsidiary, Lupin Pharmaceuticals, Inc. has been granted final
approval for Suprax (Cefixime) chewable tablets 100 mg, 150 mg and
200 mg by the USFDA. Lupin is the only company to get approval for the
chewable form.
Sun Pharma gets USFDA nod for generic Strattera Capsules
USFDA has granted Sun Pharma’s subsidiary approval for its abbreviated
new drug application (ANDA) to market a generic version of Strattera -
atomoxetine hydrochloride capsules. These generic atomoxetine
hydrochloride capsules are equivalent to Eli Lilly's Strattera capsules and
include six strengths: 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, and 100 mg.
Annual sales in the US for these strengths of branded and generic
atomoxetine hydrochloride capsules is estimated at over US$530 million.
Atomoxetine Hydrochloride capsules are indicated for the management
of attention deficit hyperactivity disorder in children aged six and older,
teens and adults.
USFDA grants approval to two drugs of Sun Pharma
USFDA has granted approval to Sun Pharma to market Desloratadine
tablets and diltiazem Hydrochloride Capsules in the US market.
Desloratadine tablets are the generic version of Schering Plough’s
Clarinex tablets, which are used in the treatment of seasonal allergic
rhinitis, perennial allergic rhinitis and chronic idiopathic urticaria. The
Clarinex tablets have annual sales of approximately US$212 million in the
US market. Diltiazem Hydrochloride Capsules are the generic version of
Biovail Corporation’s Tiazac Capsules. Diltiazem Hydrochloride capsules
have annual sales of around US$46 million in the US.
Sun Pharma receives USFDA nod for generic Alzheimer's drug
Sun has received tentative approval from the USFDA to market generic
donepezil hydrochloride tablets used for treating Alzheimer's disease in
the American market. Donepezil hydrochlorides tablets are generic
version of drug major Eisai's Aricept tablets. Annual sales of Aricept in
the US s are approximately US$2.5 billion.
New launches
Ranbaxy launches generic Aricept in US market
Ranbaxy Laboratories launched Donepezil Hydrochloride 5 mg and 10
mg tablets with 180 days exclusivity in US market after receiving USFDA
approval for its ANDA. The drug is the generic version of Eisai Co’s
Aricept tablets, which is used to treat Alzheimer’s disease. According to
ORG IMS, the annual sales of the drug in the US market are US$2.6
billion. The drug was also launched by authorised generic player
Greenstone in the US market. Ranbaxy recently declared its results for
the quarter ended September 2010. The net sales increased by 10% to |
1884 crore while net profit spurted by 167% to | 308 crore. The rise in
net profit was mainly due to forex gain of | 260 crore.
Cadila to market Amarillo Biosciences’ Maxisal tablets in India, Nepal
Cadila Healthcare has in-licensed Amarillo Biosciences Inc’s Maxisal
tablets to market those in India and Nepal. Maxisal enhances salivary
function, promotes oral comfort and helps relieve a dry mouth. In the US
market, these tablets are marketed by Amarillo Biosciences Inc only.
Opto Circuits subsidiary launches CO2
/N2O module
Opto Circuits India’s wholly owned subsidiary Criticare Systems
launched its next-generation CO2
/N2O module. The module is a compact
version of the proven Criticare Systems Poet series COs detection
technology. Recently, its other owned subsidiary Eurocor GmbH
launched second generation transluminal angioplasty balloon technology
Freeway. The technology used for the treatment of critical limb ischemia
associated with peripheral arterial disease (PAD).
IP issues
J&J sues Lupin for generic Darunavir
Johnson & Johnson’s subsidiary Tibotec has sued Lupin related to patent
issue of HIV drug Prezista. Prezista blocks infected cells from making new
copies of HIV. Lupin is seeking USFDA approval to sell the generic drug
under compound name Darunavie Ethanolate. Apart from Lupin, J&J also
sued Mylan for the same reason. The patent of the drug is set to expire in
2026. The sale of the drug in the nine months ending September 2010 in
the US market was US$290 million, up 35% over the corresponding
previous period.
Astellas Pharma, Tarix Pharma sues Glenmark for Hydrocortisone
Butyrate Cream
Triax Pharmaceuticals and Astellas Pharma have sued Glenmark
Pharmaceuticals for patent infringement related to Hydrocortisone
Butrate cream. Glenmark is the first applicant to file an ANDA with Para
IV certification to USFDA for seeking approval for generic version Locoid
Lipocream. The Astellas and Triax suit was filed under the provision of
the Hatch-Waxman Act resulting in a stay of final FDA approval of
Glenmark’s ANDA for up to 30 months or until final resolution of the
matter before the court, whichever occurs sooner. Glenmark will get 180
days exclusivity for the cream. According to IMS Health, the sales for the
12 months ending September 2010 were US$ 38 million.
Roche sues Dr Reddy’s over Boniva patent
Roche has sued Dr Reddy’s Laboratories for patent infringement
involving its osteoporosis drug Boniva (ibandronate sodium). This is the
fourth time that Roche has sued Dr Reddy’s Laboratories. Boniva, a oncea-month drug, is used in treating or preventing post-menopausal osteoporosis.
Celgene sues NATCO over Revlimid
Celgene Corporation has filed a lawsuit against Natco in connection with
Natco's filing of an abbreviated new drug application (ANDA) with the
USFDA seeking approval to market Lenalidomide Capsules, in strengths
of 5 mg, 10 mg, 15 mg and 25 mg. Lenalidomide has been used to treat
both inflammatory disorders and cancers. Natco's Lenalidomide capsules
are generic versions of Celgene's Revlimid. Based on available
information, Natco believes it may be a "first applicant" to file an ANDA
for the generic versions of Revlimid and, should its ANDA be approved, it
may be entitled to 180 days of generic market exclusivity.
Ranbaxy sues AstraZeneca in UK Court over Ulcer Treatment Patents
Ranbaxy Laboratories sued Astra Zeneca Plc in the UK over claims that
its European patents for the best-selling ulcer treatment Nexium are
invalid, two years after settling a related US case. Ranbaxy is also
seeking a court order that it will not infringe the patents if it starts selling
generic Nexium in the UK market.
Sun Pharma loses generic challenge in US court
Sun Pharmaceutical Industries has lost an opportunity to launch the
generic version of a schizophrenia drug that had generated revenues of
$4 billion (| 18,150 crore) in the US market in 2009. With some other
generic drug majors, Sun Pharma lost a patent battle against Japanese
drug major Otsuka and its US business partner, Bristol Myers Squibb
(BMS). A favourable decision in this regard would have seen the
company launching a low-cost version of Abilify (aripiprazole), during the
year. The district court of New Jersey had ruled that Abilify had patent
protection and exclusive marketing rights till 2015.
Financial performance
Aurobindo Pharma net up 92% on huge forex gains
The net sales of Aurobindo Pharma increased 26% YoY to | 1112 crore
for the quarter ended September 2010, on the back of healthy growth in
the ARV business by 48.5% and sales from European regions by 54.7%.
However, SSP’s business continued to de-grow in the second quarter of
the current fiscal by 6% to | 160 crore. Forex gain of | 76 crore
compared to forex loss of | 4 crore in the corresponding previous period
boosted the net profit by 92% to | 198 crore. On like-to-like basis, growth
in net profit excluding forex impact was 14%. Till date, the company has
filed 185 ANDAs and 151 DMFs with the USFDA. It received approval for
126 ANDAs till date, which includes 29 tentative approvals. Of this, 67
were launched in the US market.
Cipla’s net dips 5% despite 15% rise in sales
Cipla’s net sales rose by 15% to | 1580 crore in the quarter ended
September 2010 on the back of an increase in sales from domestic
markets by 20% to | 756 crore. However, the operating profit plunged by
370 bps due to increased overheads cost as it commissioned the Indore
SEZ. Although production has started from this SEZ, it is yet to receive
approval from all major regulatory authorities. The inspection by WHO
and MCC South Africa was completed in October and the company
expects to receive approvals from the UK and Australian regulatory
authorities in the current fiscal. On the other hand, realisation was also
impacted due to the appreciation of the rupee against various currencies
on a YoY basis. Thus, the net profit declined by 5% to | 263 crore. Cipla
expects to launch Seroflo inhaler in South Africa and CIS markets in the
current quarter, which will improve the sales in the second half. Doubledigit growth in the domestic market, the Seroflo inhaler launch in South
Africa and CIS markets and ramp-up in the Indore SEZ will improve the
overall sales guidance from earlier growth rate of 8-10% to 10-15%.
Dishman continues to post poor performance
Dishman Pharmaceutical disappointed once again with financial results
for the quarter ended September 2010. The net sales declined by 2%
YoY to | 213 crore as both the CRAMS and MM business witnessed degrowth of 1% and 7%, respectively. The fall in sales was mainly on the
back of postponement of order worth US$6.5 million from EU customer.
However, Dishman is confidence of executing this order in the second
half. The company has signed an agreement for the CRAMS business
with a US-based MNC and is in advanced talks with more MNCs. The
sales in both deals will start in the second half of FY12. The Unit 9 of the
Bavla facility was commissioned during the quarter. This facility is used
to manufacture Category 4 (HiPo) of oncology products. It is also in
advanced stage of talks with five more companies to manufacture their
products at this facility. The Unit 10 of Bavla complex will start
production in Q4 of the current fiscal.
Divi’s net profit plunges 15% on dip in EBITDA margin
Net sales of Divi’s Laboratories rose by 13% to | 255 crore for the
quarter ended September 2010. Higher contribution from lower margin
products in the generic segment, rupee appreciation and slower pick-up
in custom synthesis business affected the EBITDA margins that declined
by 1330 bps to 33.9%. EBITDA fell by 18% to | 88 crore. An increase in
other income by 67% resulted in net profit de-growth of 15% at | 72
crore. Divis filed two DMFs with the USFDA during the quarter. The new
manufacturing facility at Vishakhapatnam is expected to get
commissioned in FY12.
Elder Pharma net profit up 47%
Elder Pharmaceutical’s sales increased by 20% to | 211 crore for the
quarter ended September 2010. The increase in sales was mainly due to
improved sales of brands Shelcal, Formic, Eldervit, etc. An expansion in
the EBITDA margin by 300 bps to 19.9% boosted the net profit that
increased by 47% to | 14 crore. The company is planning to launch
Shelcal-K in the quarter. It expects the Shelcal brand to continue to do
well in the current fiscal and aims to register sales of | 180-200 crore in
the current fiscal. It is planning to launch 12-14 products in the next 18
months.
Jubilant sales up mere 6% on lower growth in PLSPS segment
Jubilant Life Sciences registered marginal growth of 6% in net sales to |
988 crore for the quarter ended September 2010 due to a mere growth of
3% in its PLSPS segment to | 850 crore. The drug discovery &
development services (DDDS) segment witnessed de-growth of 18%
during the quarter due to consolidation in the clinical research industry in
North America dragging overall growth in the PLSPS segment. The
EBITDA margin declined 390 bps to 16.1% due to pricing pressure and
unfavourable exchange rates. Forex loss during the quarter was | 0.65
crore as against loss of | 43 crore in the corresponding previous period.
Despite a fall in sales and EBITDA margins, the decrease in forex losses
boosted sales to increase by 42% to | 82 crore. Jubilant signed contracts
worth US$84 million with leading MNCs. The capacity expansion in
Pyridines, Niacinamide and API facilities will drive the growth in revenues
and profits.
Natco Pharma Q2 net up 11%
Natco Pharma’s net profit increased 11% to | 14.82 crore for the quarter
ended September 2010 on an 8% increase in sales to | 127 crore. The
company is planning to raise | 100 crore to fund its expansion plans and
research activities.
M & As
Dr Reddy’s buys GSK’s Penicillin facility
Dr Reddy’s Laboratories has signed an agreement with GlaxoSmithKline
to buy GSK’s US oral penicillin facility and product portfolio. As per
agreement, GSK will transfer ownership of its penicillin manufacturing
facility and rights for the Augmentin and Amoxil brands in the US to Dr
Reddy’s. GSK will retain the existing rights for these brands outside the
US. The proposed transaction is expected to be completed by the first
half of 2011. Patents of both drugs expired and there is significant
competition for both brands. As per industry estimates, two brands had
sales of US$73 million in 2009.
Elder Pharma completes acquisition of NeutraHealth
Elder Pharmaceuticals has completed the acquisition of UK-based
NeutraHealth for nearly £ 9.8 million. NeutraHealth has become a whollyowned subsidiary as it increased its stake from 21%. Elder Pharma has
offered a price of 6.5 pence per share. NeutraHealth focuses on the
highly fragmented vitamins, minerals and supplements sector within the
UK and Europe. It has three group companies -- Biocare, Brunel
Healthcare and Totally Nourish.
Opto Circus acquires Unetixs Vascular’s detection & diagnostics
products
Opto Circuits has bought the detection and diagnostics business of
Unetixis Vascular. The company has said it had made the investment as
a measure towards increasing the size of its portfolio and offering. The
move is geared towards expanding the firm’s presence in the detection
and diagnostics space and will go a long way in complementing and
reinforcing Opto Circuits’ product portfolio investment in Criticare
Systems Inc’s vital signs monitoring line and pulse oximetry sensors.
Sun Pharma increases stake in Taro to 65%
Sun Pharmaceutical Industries has increased its stake in Taro
Pharmaceutical Industries from 53% to 65% after acquiring shares from
Templeton Asset Management for US$82 million. Sun Pharma, through
its indirect subsidiary Alkaloida Chemical Company has bought 5.16
million ordinary shares from Templeton Asset Management. Sun Pharma
paid US$16 per Taro share to Templeton, a price which is at least 30%
based on Taro’s six-month average closing share price.
R & D Developments
Glenmark completes Phase III trails for Crofelemer
Glenmark Pharmaceuticals completed Phase III trails for its in-licensed
drug Crofelemer. Crofelemer is an anti-diarrhoeal drug used for HIV
related diarrhoea. Glenmark has exclusive marketing and distribution
rights for the drug for 140 countries. Glenmark has in-licensed the
Crofelemer from Napo Pharmaceuticals. The drug will be marketed by
Salix Pharmaceutical in the US & EU market according to a tie-up
between Salix and Napo Pharmaceuticals. Glenmark and Salix Pharma
have signed an agreement where Glenmark will be supplying API for
Crofelemer to Salix Pharma. Glenmark expects to launch Crofelemer in
Indian markets in 2012.
Investments
Elder Pharma to spend €2 million for soft gel unit in Bulgaria
Elder Pharmaceuticals is planning to spend €2 million to set up a soft gel
manufacturing facility in Bulgaria. The company operates in the Bulgarian
market through its subsidiary Elder Biomeda. Elder increased its stake
from 61% to 92.2% recently. Till date, the company has spent around |
40 crore for upgrading its facilities and increasing stake in Biomeda.
Orchid to invest | 200 crore in niche segment
Orchid Chemicals and Pharmaceuticals is planning to invest around | 200
crore to enter niche segments like immuno suppressants and
ophthalmology. The company also redeemed US$25.7 million worth of
foreign currency convertible bond (FCCB), raised in 2005. Another
tranche of FCCB totalling around US$117 million will mature in
November 2012.
Other developments
Aurobindo to tie up with Pfizer for Japan & Korea foray
Aurobindo Pharma will be joining hands with Pfizer yet again, this time
for exploring the fast growing Japanese and Korean generics market.
The company is expected to sign another deal with Pfizer to this effect,
shortly. The company now has a strategic alliance with Pfizer to market
about 100 products in geographies including the US, Europe and other
emerging markets. It proposes to manufacture about 30 active
pharmaceutical ingredients (APIs) to Pfizer, which, in turn, will take care
of packaging and branding. Pfizer already has three formulation units in
Japan. Aurobindo would specially renovate one of its plants in AP at an
investment of US$8 million, which would adhere to all the regulatory
norms of the Japanese government.
Biocon to list Syngene in May 2012
Biocon is planning to spin off its contract research unit Syngene by May
2012. The company is planning an initial public offering of Syngene
during the next 18 to 24 months and expects to hire as many as 500
people in India by December 2011.
Biocon to strengthen Orlistat market presence after ban on sibutramine
Biocon is gearing up to strengthen the marketing of Orlistat, its obesity
drug, after the ban on the marketing of sibutramine, R-sibutramine and
their formulations by the Drugs Control General of India. Orlistat is
considered to be a safe drug and is manufactured using fermentation
technology. The drug does not have any side effects as is the case with
other drugs such as rimonabant, which causes suicidal tendencies.
Sibutramine was reported to cause increased arterial blood pressure and
heart rate.
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