Please Share:: 
India Equity Research Reports, IPO and Stock News
Visit http://indiaer.blogspot.com/ for complete details �� ��
Good start to earnings season…
In April, the quarterly earning season started on a positive note. Three
companies (from the Pharma Pill coverage) namely Strides Arcolab,
Biocon and Indoco declared their quarterly numbers. While Strides and
Indoco’s results were almost in line, Biocon’s numbers were a bit muted
on account of slower growth at German Subsidiary Axicorp. No wonder,
Biocon decided to offload its entire stake in Axicorp as it would have
affected the overall profitability, going ahead. Strides received the long
awaited USFDA approval for its new oncology facility in Bangalore after
acquiring approval for its new non-sterile facility in the same premises.
In this month, we also saw two small but significant deals struck by
MNCs with Indian leaders for different geographies. While Merck Inc,
through its subsidiary MSD, entered into a JV with Sun Pharma to market
branded generics in emerging markets, Abbott entered into a licensing
agreement with Lupin for eight patents on cholesterol-lowering drug
Fenofibrate. On the litigation front, a US district court rejected Mylan’s
plea against the USFDA and Ranbaxy over cholesterol-lowering Lipitor,
making Ranbaxy’s path clear for the launch.
Sector view
In April, the BSE Healthcare index outperformed the broader market after
almost three months of under performance. This, we believe, was on
account of steady FII net inflows in March and April after two months of
selling. We expect the Healthcare index to outperform the broader
markets on account of increased headwinds due to inflation and
hardening interest rates. Good traction from the US, Japan and other
developed markets supported by product approvals, a growing presence
in Pharmerging markets and a strong foothold in India are some of the
aspects that will continue to weigh on the relative outperformance vis-àvis
broader markets.
Regulatory approvals
Aurobindo gets USFDA approval for generic Effexor XR capsules
Aurobindo Pharma has received USFDA approval for Venlafaxine
Hydrochloride extended release capsules 37.5 mg, 75 mg and 150 mg.
The drug is the generic version of Wyeth Pharmaceutical Inc’s Effexor XR
capsules. Effexor XR capsules are used for the treatment of major
depressive disorders and fall under the neurological therapeutic
category. The product has a market size of approximately US$2.4 billion
for the 12 months ending September 2010 as per IMS. It is planning to
launch the drug after June 1, 2011.
Lupin gets FDA tentative approval for Metformin Hydrochloride tablets
The US subsidiary of Lupin has received tentative approval for its
Metformin Hydrochloride extended-release tablets, 500 mg and 1000 mg
strengths from the USFDA. Lupin's Metformin Hydrochloride extendedrelease
tablets are the AB-rated generic equivalent of Andrx Labs LLC's
Fortamet 500 mg and 1000 mg tablets. Fortamet is indicated as an
adjunct to diet and exercise to improve glycemic control in adults with
Type 2 diabetes mellitus. The annual sales for Fortamet in the US were
US$83 million for the 12 months ended December 2010, as per IMS
Health Data.
Aurobindo gets USFDA nod for Divalproex Sodium
Aurobindo Pharma has received final approval for Divalproex Sodium
delayed release tablets in multiple strengths of 125 mg, 250 mg and 500
mg from the USFDA. The drug is a generic version of Abbott
Laboratories Depakote delayed release tablets. Divalproex sodium
tablets falls under the neurological (CNS) therapeutic category and are
indicated for the treatment of manic episodes associated with bipolar
disorder as monotherapy and adjunctive therapy in the treatment of
patients with complex partial seizures that occur either in isolation or in
association with other types of seizures and for prophylaxis of migraine
headaches. The drug has a market size of US$144 million for the 12
months ending September 2010.
Unichem receives USFDA nod for generic Depakote tablets
Unichem Laboratories has received approval from the USFDA for
Divalproex Sodium Delayed Release Tablets USP 125 mg, 250 mg and
500 mg (Valproic Acid Activity). The Divalproex Sodium delayed release
tablets are therapeutically equivalent to Abbott Laboratories' Depakote
delayed-release tablets. These are indicated as sole and adjunctive
therapy for the treatment of complex partial seizures that occur either in
isolation or in association with other types of seizures.
Manufacturing facility Approval
Strides gets USFDA approval for oncology facility
Onco Therapies Ltd, a division of Agila that is a wholly-owned subsidiary
of Strides Arcolab has received approval from the USFDA for its
oncology facility in Bangalore. This will enable Strides to play a more
significant role in the global oncology industry. Consequent to the
approval, Strides expects to begin receiving ANDA approvals for
oncology products for which filings have already been made.
Financial Results
Biocon Q4FY11 net up 25% YoY
Biocon’s net sales grew 7% YoY to | 701.6 crore due to marginal growth
in the biopharmaceutical business to | 613 crore. The research services
business witnessed 20% YoY growth to | 88.7 crore. EBITDA margins
expanded ~60 bps YoY to 22.4% as Axicorp’s contribution as a
percentage of sales declined 37.8% to 33.1%. Margins would have
further improved but employee cost as percentage of sales increased by
200 bps to 11.7%. EBITDA, in value terms, increased only 10% to | 145.1
crore. Despite marginal 10% growth at the EBITDA level, the net profit
increased 25% to | 100.8 crore on the back of lower tax provision and
higher other income. The tax rate was lower by 450 bps YoY. Other
income was higher by 78% to | 13.3 crore due to dividend on liquid
investment.
Indoco Remedies net up 48% YoY
Indoco Remedies’ net sales increased 10.6% to | 120.4 crore. The
growth in sales was driven by healthy growth in APIs and formulation
exports to regulated markets. EBITDA margins expanded 333 bps to
14.9% due to a change in the product mix. Raw material cost and R&D as
a percentage of sales declined by 660 bps and 50 bps, respectively.
EBITDA increased by 42% to | 18 crore. With lower interest cost (down
by 13% to | 0.63 crore), the net profit grew by 48% to | 12.2 crore.
Strides’ revenues up 30% YoY, net profit up mere 2% YoY
Strides Arcolab's Q1CY11 results were a mixed bag. Revenues increased
30% YoY to | 497.3 crore on account of higher licensing income (| 112.1
crore). However, EBITDA margins declined 210 bps YoY to 20.4% due to
consolidation of the Brazilian JV and planned shutdown of the USFDA
approved existing sterile manufacturing facility for seven weeks. EBITDA
grew 18% to | 101.5 crore. Due to higher interest cost and tax provision,
net profit growth was restricted to 2% at | 40.7 crore. Strides received
USFDA approval for a new sterile manufacturing facility recently.
R&D developments
Cadila Healthcare receives USFDA approval for IND ZYGK1
Cadila Healthcare has received approval from the USFDA for its IND
application of ZYGK1. The new molecular entity (NME) is a potent and
orally administered small molecule glucokinase activator. The company
will now initiate Phase I clinical trials for ZYGK1. Glucokinase (GK) is the
enzyme that acts as a glucose sensor in the pancreas and regulates
glucose metabolism in the liver. When circulating glucose levels rise
above a certain threshold, the glucokinase enzyme enhances insulin
release from pancreas and decreases glucose production in liver. In
normal individuals, the pancreas secretes insulin in response to
increased levels of glucose in the blood. In patients with Type 2 diabetes,
there is a reduction of GK activity in the pancreas and the liver.
IP issues
Takeda sues Dr Reddy’s over Dexilant capsules
Takeda Pharmaceutical has filed a patent infringement suit against Dr
Reddy's in a New York Court over the generic version of Dexilant.
Dexilant is used to treat gastroesophageal reflux disease (GERD), a
condition in which stomach acid backflows (refluxes) into the
oesophagus, causing heartburn and possible injury to the oesophagus.
Dr Reddy’s filed ANDA with Paragraph IV certification stating that the
patents related to two strengths of Dexilant are invalid. These patents are
set to expire in June 2020 and August 2026. The annual sales of Dexilant
delayed-release capsules, 30 mg and 60 mg were about $20 million and
$261 million, respectively, for the 12 months ending January 2011.
AstraZeneca sues Dr Reddy’s over pain drug
AstraZeneca and US based Pozen have sued Dr Reddy’s laboratories in a
US district court for alleged infringement of a patent related to the drug
Vimovo. The drug is a pain reliever. Dr Reddy’s filed ANDA with USFDA
seeking approval to sell its generic version of Vimovo. Vimovo was
jointly developed by Pozen and AstraZeneca. The drug is a fixed dose
combination of anti-inflammatory drug naproxen and an immediate
release version of esomeprazole, the active ingredient in AstraZeneca’s
acid reflux treatment Nexium.
Allergan sues Lupin over Zymaxid solution
The US subsidiary of Lupin has been sued by the US firm Allergan
alleging that the former would be infringing its patent coverage by
attempting to manufacture and market a generic version of Zymaxid
0.5% (Gatifloxacin ophthalmic solution) in the US market. Allergan has
been joined by Japanese drug firms Senju Pharma and Kyorin Pharma in
filing the patent violation suit against Lupin at a US district court in the
district of Delaware. Zymaxid, which Allergan claims is the highest
concentration gatifloxacin ophthalmic solution in the United States, is a
topical fluoroquinolone anti-infective used for the treatment of bacterial
conjunctivitis caused by select susceptible strains.
Lupin gets favourable decision from US judge on Antara litigation
A US federal judge has rejected Ranbaxy's bid to nix Lupin's lawsuit
seeking to block Ranbaxy from launching a generic version of the
cholesterol drug Antara. The judge denied Ranbaxy's motion to dismiss
one of three lawsuits Lupin Atlantis Holdings SA has lodged accusing the
generic drug maker of infringing the patent that covers Antara with its
proposed generic drug.
Orchid settles patent litigation with Pfizer over Effexor XR
Orchid Chemicals has reached an out-of-court settlement with Pfizer Inc
to sell a low-cost version of Pfizer's patented anti-depressant drug,
Effexor XR, (extended release) in the US market this fiscal. Wyeth, now
owned by Pfizer, had in 2009 sued Orchid to prevent it from launching its
generic version ahead of its patent expiry in 2017. Venlafaxine, sold
under the brand Effexor XR, rakes in about US$2.5 billion annually in the
US alone.
US federal court dismiss Mylan lawsuit for Lipitor
Mylan Inc’s lawsuit seeking to force the USFDA to act on Ranbaxy’s
application to sell a generic version of Lipitor was dismissed by a federal
judge in Washington. The judge ruled that drug makers cannot sue over
pending applications filed by their competitors, according to an opinion
filed in federal court in Washington. He also said Mylan’s lawsuit is
premature since an application from its Matrix Laboratories Ltd.
subsidiary to sell a copy of the cholesterol-lowering drug is still pending.
Product launches
Dr Reddy’s launches over-the-counter fexofenadine HCl tablets in US
Dr Reddy’s Laboratories has launched its over-the-counter (OTC)
fexofenadine HCl tablets in the US market as it received approval from
the USFDA for its abbreviated new drug application (ANDA). The
company will market the product under store brand labels in the US
market. The products are bioequivalent versions of Sanofi-Aventis’
Allegra tablets, which received Rx-to-OTC switch approval from the FDA
on January 24, 2011. The fexofenadine HCl Rx market had brand and
generic sales of approximately $452 million for the 12 months ending
December 31, 2010 according to IMS Health.
Opto to launch Powerheat AED in Girona & Spain
Opto Circuits (India)'s wholly owned subsidiary -- Cardiac Science
Corporation secured an overseas contract to deploy 650 Powerheat
automated external defibrillators in Girona, Spain. Most of the fully
automatic Cardiac Science AEDs will be deployed in streets or public
squares. Other defibrillators will be used to protect high-risk facilities
such as sports centres, train stations, airports and bus stations.
Ranbaxy to launch Olanzapine tablets in Spain
Ranbaxy Laboratories has announced the Day-1 launch of Olanzapine
tablets, the generic version of Zyprexa in Spain. Ranbaxy will be
introducing Olanzapine tablets 2.5 mg, 5 mg, 7.5 mg and 10 mg.
Olanzapine is an atypical antipsychotic and is indicated for the treatment
of schizophrenia in adults. Zyprexa is the innovator product of Eli Lilly
and has a market size of $210 million (Source: 2010 IMS Data). Ranbaxy
has received necessary regulatory approvals from the Spanish Health
Authorities to manufacture and market Olanzapine in Spain and will be
launching the product on Day-1, following patent expiry.
M&As , de-merger / divestment
Biocon to divest stake in Axicorp
Biocon has decided to sell its 78% stake in Axicorp for €40 million to the
existing group of promoters. It acquired Axicorp in February 2008 for €31
million mainly to market its biosimilar Insulin and Glargine in the German
market. Considering the fact that there is a 16% flat rebate emphasised
by the German market for three years for all pharma companies and the
recent global supply agreement with Pfizer, which may fulfil the
marketing requirements in Germany, Biocon has decided to divest the
stake in Axicorp.
Product recalls
Lupin recalls perindopril tablets in US market
The USFDA recalled all lots of Lupin's cholesterol-lowering drug
perindopril for "not meeting specifications overtime. This drug,
manufactured in the company's Goa facility, is one of its largest selling
drugs by revenue. The recall was limited to one batch worth around
$15,000.
Deals & alliances
Glenmark to market Immanence-IDC’s derma products in 8 countries
Glenmark Pharmaceutical has entered a 10 year agreement with
Canadian based Immanence-IDC for distributing Immanence-IDC’s antiaging
cosmeceutical products. Glenmark will market products in India,
Brazil, Mexico, South Africa, Egypt, Vietnam, Malaysia and Thailand.
Dr Reddy’s Promius Pharma to market Cloderm cream in US
Promius Pharma, an affiliate of Dr Reddy’s Laboratories, and Valeant
Pharmaceuticals International signed a collaboration agreement for
Cloderm (clocortolone pivalate 0.1%) cream. Under the agreement,
Promius Pharma will make an upfront payment and pay future royalties
as the consideration for the right to manufacture, distribute and market
Cloderm Cream in the US, effective immediately.
Lupin to market rifaximin products worldwide
Lupin has granted US-based Salix exclusive worldwide rights (except for
India) to exploit Lupin’s technology and technology jointly developed by
Lupin and Salix for all rifaximin products for human use. This agreement
expands the collaboration that Salix and Lupin entered into as of
September 30, 2009. The agreement covers the development and
commercialisation of rifaximin products and provides for Lupin to supply
Salix with rifaximin active pharmaceutical ingredient (API) and certain
finished rifaximin products. Salix is required to make a $10 million
upfront payment to Lupin along with potential US regulatory milestone
payments in respect of products covered by Lupin patents or jointly-held
patents. Royalties, as a percentage rate in the low teens, will be payable
by Salix to Lupin with respect to sales of products covered by Lupin
patents or jointly-held patents. Additionally, Salix will pay Lupin
minimum quarterly payments for product development and other
activities. Rifaximin is used in the treatment of traveller's diarrhoea and
hepatic encephalopathy, for which it received orphan drug status from
the USFDA in 1998.
Sun, Merck tie up to commercialise branded generic in emerging
markets
Sun Pharma and Merck's subsidiary MSD Pharmaceuticals have formed a
joint venture to develop, manufacture and commercialise branded
generics in emerging markets. Under the JV, Sun Pharma Advanced
Research Company (SPARC) will develop the product while Sun Pharma
will manufacture the drugs and Merck will register and market these
products in more than 100 emerging markets. Financial aspects and
selection of the product basket are yet to be decided by both companies.
The JV board can select the drugs that are in the development pipeline
of SPARC and specific products from Merck's portfolio.
Lupin signs patent license agreement with Abbott
Lupin and its subsidiaries have entered into a license agreement with US
based Abbott Laboratories and Laboratories Fournier SA for eight
patents on cholesterol-lowering drug Fenofibrate. The agreement
between the two parties also covered continuations, extensions, reissues,
re-examinations and so on. Fenofibrate was developed by
Groupe Fournier SA and acquired in 2005 by Solvay Pharmaceutical. In
late 2009, Solvay's pharma business was bought over by Abbott. Lupin
acquired Antara from bankrupt Oscient Pharmaceuticals Corp in
September 2009. Antara's patent expires in 2020. Abbott also sells a
version of fenofibrate under the brand name TriCor.
Other developments
Cipla seeks voluntary license for Isentress
Cipla has applied for a voluntary license for Merck’s Isentress stating that
the drugs is exorbitantly priced and is inaccessible to needy patients in
India. The drug Isentress is an HIV integrase inhibitor
Dr Reddy’s expands its R&D centre in Cambridge, United Kingdom
Dr Reddy’s Laboratories opened its newly expanded Chirotech
Technology Centre at Cambridge Science Park, UK where Chirotech has
been based for the last 20 years. The new 33,000 sq ft facility is purpose
built for laboratories and offices and has been fitted to Dr Reddy’s
specific requirements for chemistry, biology and analytics. The additional
capacity will facilitate an initial doubling of scientific staff in Chirotech
while providing for further capacity additions in future. It will help
strengthen core capabilities in biocatalysis and chemocatalysis, build
capabilities in fast growing segments like Activated mPEGs and peptides,
and allow development of other areas of expertise in chemistry and
processing for use in the pharmaceutical industry.
Elder Pharma plans manufacturing in Bulgaria for European market
Elder Pharma plans to start manufacturing up to six of its products at the
facility of its Bulgarian arm Elder Biomeda AD to market them in the
Europe market. The six products include products in women healthcare
and nutritional. To start with, the company plans to launch calcium
supplement Shelcal in the Bulgarian market. The company is also
planning to launch NeutraHealth product in the current fiscal.
India Equity Research Reports, IPO and Stock News
Visit http://indiaer.blogspot.com/ for complete details �� ��
Good start to earnings season…
In April, the quarterly earning season started on a positive note. Three
companies (from the Pharma Pill coverage) namely Strides Arcolab,
Biocon and Indoco declared their quarterly numbers. While Strides and
Indoco’s results were almost in line, Biocon’s numbers were a bit muted
on account of slower growth at German Subsidiary Axicorp. No wonder,
Biocon decided to offload its entire stake in Axicorp as it would have
affected the overall profitability, going ahead. Strides received the long
awaited USFDA approval for its new oncology facility in Bangalore after
acquiring approval for its new non-sterile facility in the same premises.
In this month, we also saw two small but significant deals struck by
MNCs with Indian leaders for different geographies. While Merck Inc,
through its subsidiary MSD, entered into a JV with Sun Pharma to market
branded generics in emerging markets, Abbott entered into a licensing
agreement with Lupin for eight patents on cholesterol-lowering drug
Fenofibrate. On the litigation front, a US district court rejected Mylan’s
plea against the USFDA and Ranbaxy over cholesterol-lowering Lipitor,
making Ranbaxy’s path clear for the launch.
Sector view
In April, the BSE Healthcare index outperformed the broader market after
almost three months of under performance. This, we believe, was on
account of steady FII net inflows in March and April after two months of
selling. We expect the Healthcare index to outperform the broader
markets on account of increased headwinds due to inflation and
hardening interest rates. Good traction from the US, Japan and other
developed markets supported by product approvals, a growing presence
in Pharmerging markets and a strong foothold in India are some of the
aspects that will continue to weigh on the relative outperformance vis-àvis
broader markets.
Regulatory approvals
Aurobindo gets USFDA approval for generic Effexor XR capsules
Aurobindo Pharma has received USFDA approval for Venlafaxine
Hydrochloride extended release capsules 37.5 mg, 75 mg and 150 mg.
The drug is the generic version of Wyeth Pharmaceutical Inc’s Effexor XR
capsules. Effexor XR capsules are used for the treatment of major
depressive disorders and fall under the neurological therapeutic
category. The product has a market size of approximately US$2.4 billion
for the 12 months ending September 2010 as per IMS. It is planning to
launch the drug after June 1, 2011.
Lupin gets FDA tentative approval for Metformin Hydrochloride tablets
The US subsidiary of Lupin has received tentative approval for its
Metformin Hydrochloride extended-release tablets, 500 mg and 1000 mg
strengths from the USFDA. Lupin's Metformin Hydrochloride extendedrelease
tablets are the AB-rated generic equivalent of Andrx Labs LLC's
Fortamet 500 mg and 1000 mg tablets. Fortamet is indicated as an
adjunct to diet and exercise to improve glycemic control in adults with
Type 2 diabetes mellitus. The annual sales for Fortamet in the US were
US$83 million for the 12 months ended December 2010, as per IMS
Health Data.
Aurobindo gets USFDA nod for Divalproex Sodium
Aurobindo Pharma has received final approval for Divalproex Sodium
delayed release tablets in multiple strengths of 125 mg, 250 mg and 500
mg from the USFDA. The drug is a generic version of Abbott
Laboratories Depakote delayed release tablets. Divalproex sodium
tablets falls under the neurological (CNS) therapeutic category and are
indicated for the treatment of manic episodes associated with bipolar
disorder as monotherapy and adjunctive therapy in the treatment of
patients with complex partial seizures that occur either in isolation or in
association with other types of seizures and for prophylaxis of migraine
headaches. The drug has a market size of US$144 million for the 12
months ending September 2010.
Unichem receives USFDA nod for generic Depakote tablets
Unichem Laboratories has received approval from the USFDA for
Divalproex Sodium Delayed Release Tablets USP 125 mg, 250 mg and
500 mg (Valproic Acid Activity). The Divalproex Sodium delayed release
tablets are therapeutically equivalent to Abbott Laboratories' Depakote
delayed-release tablets. These are indicated as sole and adjunctive
therapy for the treatment of complex partial seizures that occur either in
isolation or in association with other types of seizures.
Manufacturing facility Approval
Strides gets USFDA approval for oncology facility
Onco Therapies Ltd, a division of Agila that is a wholly-owned subsidiary
of Strides Arcolab has received approval from the USFDA for its
oncology facility in Bangalore. This will enable Strides to play a more
significant role in the global oncology industry. Consequent to the
approval, Strides expects to begin receiving ANDA approvals for
oncology products for which filings have already been made.
Financial Results
Biocon Q4FY11 net up 25% YoY
Biocon’s net sales grew 7% YoY to | 701.6 crore due to marginal growth
in the biopharmaceutical business to | 613 crore. The research services
business witnessed 20% YoY growth to | 88.7 crore. EBITDA margins
expanded ~60 bps YoY to 22.4% as Axicorp’s contribution as a
percentage of sales declined 37.8% to 33.1%. Margins would have
further improved but employee cost as percentage of sales increased by
200 bps to 11.7%. EBITDA, in value terms, increased only 10% to | 145.1
crore. Despite marginal 10% growth at the EBITDA level, the net profit
increased 25% to | 100.8 crore on the back of lower tax provision and
higher other income. The tax rate was lower by 450 bps YoY. Other
income was higher by 78% to | 13.3 crore due to dividend on liquid
investment.
Indoco Remedies net up 48% YoY
Indoco Remedies’ net sales increased 10.6% to | 120.4 crore. The
growth in sales was driven by healthy growth in APIs and formulation
exports to regulated markets. EBITDA margins expanded 333 bps to
14.9% due to a change in the product mix. Raw material cost and R&D as
a percentage of sales declined by 660 bps and 50 bps, respectively.
EBITDA increased by 42% to | 18 crore. With lower interest cost (down
by 13% to | 0.63 crore), the net profit grew by 48% to | 12.2 crore.
Strides’ revenues up 30% YoY, net profit up mere 2% YoY
Strides Arcolab's Q1CY11 results were a mixed bag. Revenues increased
30% YoY to | 497.3 crore on account of higher licensing income (| 112.1
crore). However, EBITDA margins declined 210 bps YoY to 20.4% due to
consolidation of the Brazilian JV and planned shutdown of the USFDA
approved existing sterile manufacturing facility for seven weeks. EBITDA
grew 18% to | 101.5 crore. Due to higher interest cost and tax provision,
net profit growth was restricted to 2% at | 40.7 crore. Strides received
USFDA approval for a new sterile manufacturing facility recently.
R&D developments
Cadila Healthcare receives USFDA approval for IND ZYGK1
Cadila Healthcare has received approval from the USFDA for its IND
application of ZYGK1. The new molecular entity (NME) is a potent and
orally administered small molecule glucokinase activator. The company
will now initiate Phase I clinical trials for ZYGK1. Glucokinase (GK) is the
enzyme that acts as a glucose sensor in the pancreas and regulates
glucose metabolism in the liver. When circulating glucose levels rise
above a certain threshold, the glucokinase enzyme enhances insulin
release from pancreas and decreases glucose production in liver. In
normal individuals, the pancreas secretes insulin in response to
increased levels of glucose in the blood. In patients with Type 2 diabetes,
there is a reduction of GK activity in the pancreas and the liver.
IP issues
Takeda sues Dr Reddy’s over Dexilant capsules
Takeda Pharmaceutical has filed a patent infringement suit against Dr
Reddy's in a New York Court over the generic version of Dexilant.
Dexilant is used to treat gastroesophageal reflux disease (GERD), a
condition in which stomach acid backflows (refluxes) into the
oesophagus, causing heartburn and possible injury to the oesophagus.
Dr Reddy’s filed ANDA with Paragraph IV certification stating that the
patents related to two strengths of Dexilant are invalid. These patents are
set to expire in June 2020 and August 2026. The annual sales of Dexilant
delayed-release capsules, 30 mg and 60 mg were about $20 million and
$261 million, respectively, for the 12 months ending January 2011.
AstraZeneca sues Dr Reddy’s over pain drug
AstraZeneca and US based Pozen have sued Dr Reddy’s laboratories in a
US district court for alleged infringement of a patent related to the drug
Vimovo. The drug is a pain reliever. Dr Reddy’s filed ANDA with USFDA
seeking approval to sell its generic version of Vimovo. Vimovo was
jointly developed by Pozen and AstraZeneca. The drug is a fixed dose
combination of anti-inflammatory drug naproxen and an immediate
release version of esomeprazole, the active ingredient in AstraZeneca’s
acid reflux treatment Nexium.
Allergan sues Lupin over Zymaxid solution
The US subsidiary of Lupin has been sued by the US firm Allergan
alleging that the former would be infringing its patent coverage by
attempting to manufacture and market a generic version of Zymaxid
0.5% (Gatifloxacin ophthalmic solution) in the US market. Allergan has
been joined by Japanese drug firms Senju Pharma and Kyorin Pharma in
filing the patent violation suit against Lupin at a US district court in the
district of Delaware. Zymaxid, which Allergan claims is the highest
concentration gatifloxacin ophthalmic solution in the United States, is a
topical fluoroquinolone anti-infective used for the treatment of bacterial
conjunctivitis caused by select susceptible strains.
Lupin gets favourable decision from US judge on Antara litigation
A US federal judge has rejected Ranbaxy's bid to nix Lupin's lawsuit
seeking to block Ranbaxy from launching a generic version of the
cholesterol drug Antara. The judge denied Ranbaxy's motion to dismiss
one of three lawsuits Lupin Atlantis Holdings SA has lodged accusing the
generic drug maker of infringing the patent that covers Antara with its
proposed generic drug.
Orchid settles patent litigation with Pfizer over Effexor XR
Orchid Chemicals has reached an out-of-court settlement with Pfizer Inc
to sell a low-cost version of Pfizer's patented anti-depressant drug,
Effexor XR, (extended release) in the US market this fiscal. Wyeth, now
owned by Pfizer, had in 2009 sued Orchid to prevent it from launching its
generic version ahead of its patent expiry in 2017. Venlafaxine, sold
under the brand Effexor XR, rakes in about US$2.5 billion annually in the
US alone.
US federal court dismiss Mylan lawsuit for Lipitor
Mylan Inc’s lawsuit seeking to force the USFDA to act on Ranbaxy’s
application to sell a generic version of Lipitor was dismissed by a federal
judge in Washington. The judge ruled that drug makers cannot sue over
pending applications filed by their competitors, according to an opinion
filed in federal court in Washington. He also said Mylan’s lawsuit is
premature since an application from its Matrix Laboratories Ltd.
subsidiary to sell a copy of the cholesterol-lowering drug is still pending.
Product launches
Dr Reddy’s launches over-the-counter fexofenadine HCl tablets in US
Dr Reddy’s Laboratories has launched its over-the-counter (OTC)
fexofenadine HCl tablets in the US market as it received approval from
the USFDA for its abbreviated new drug application (ANDA). The
company will market the product under store brand labels in the US
market. The products are bioequivalent versions of Sanofi-Aventis’
Allegra tablets, which received Rx-to-OTC switch approval from the FDA
on January 24, 2011. The fexofenadine HCl Rx market had brand and
generic sales of approximately $452 million for the 12 months ending
December 31, 2010 according to IMS Health.
Opto to launch Powerheat AED in Girona & Spain
Opto Circuits (India)'s wholly owned subsidiary -- Cardiac Science
Corporation secured an overseas contract to deploy 650 Powerheat
automated external defibrillators in Girona, Spain. Most of the fully
automatic Cardiac Science AEDs will be deployed in streets or public
squares. Other defibrillators will be used to protect high-risk facilities
such as sports centres, train stations, airports and bus stations.
Ranbaxy to launch Olanzapine tablets in Spain
Ranbaxy Laboratories has announced the Day-1 launch of Olanzapine
tablets, the generic version of Zyprexa in Spain. Ranbaxy will be
introducing Olanzapine tablets 2.5 mg, 5 mg, 7.5 mg and 10 mg.
Olanzapine is an atypical antipsychotic and is indicated for the treatment
of schizophrenia in adults. Zyprexa is the innovator product of Eli Lilly
and has a market size of $210 million (Source: 2010 IMS Data). Ranbaxy
has received necessary regulatory approvals from the Spanish Health
Authorities to manufacture and market Olanzapine in Spain and will be
launching the product on Day-1, following patent expiry.
M&As , de-merger / divestment
Biocon to divest stake in Axicorp
Biocon has decided to sell its 78% stake in Axicorp for €40 million to the
existing group of promoters. It acquired Axicorp in February 2008 for €31
million mainly to market its biosimilar Insulin and Glargine in the German
market. Considering the fact that there is a 16% flat rebate emphasised
by the German market for three years for all pharma companies and the
recent global supply agreement with Pfizer, which may fulfil the
marketing requirements in Germany, Biocon has decided to divest the
stake in Axicorp.
Product recalls
Lupin recalls perindopril tablets in US market
The USFDA recalled all lots of Lupin's cholesterol-lowering drug
perindopril for "not meeting specifications overtime. This drug,
manufactured in the company's Goa facility, is one of its largest selling
drugs by revenue. The recall was limited to one batch worth around
$15,000.
Deals & alliances
Glenmark to market Immanence-IDC’s derma products in 8 countries
Glenmark Pharmaceutical has entered a 10 year agreement with
Canadian based Immanence-IDC for distributing Immanence-IDC’s antiaging
cosmeceutical products. Glenmark will market products in India,
Brazil, Mexico, South Africa, Egypt, Vietnam, Malaysia and Thailand.
Dr Reddy’s Promius Pharma to market Cloderm cream in US
Promius Pharma, an affiliate of Dr Reddy’s Laboratories, and Valeant
Pharmaceuticals International signed a collaboration agreement for
Cloderm (clocortolone pivalate 0.1%) cream. Under the agreement,
Promius Pharma will make an upfront payment and pay future royalties
as the consideration for the right to manufacture, distribute and market
Cloderm Cream in the US, effective immediately.
Lupin to market rifaximin products worldwide
Lupin has granted US-based Salix exclusive worldwide rights (except for
India) to exploit Lupin’s technology and technology jointly developed by
Lupin and Salix for all rifaximin products for human use. This agreement
expands the collaboration that Salix and Lupin entered into as of
September 30, 2009. The agreement covers the development and
commercialisation of rifaximin products and provides for Lupin to supply
Salix with rifaximin active pharmaceutical ingredient (API) and certain
finished rifaximin products. Salix is required to make a $10 million
upfront payment to Lupin along with potential US regulatory milestone
payments in respect of products covered by Lupin patents or jointly-held
patents. Royalties, as a percentage rate in the low teens, will be payable
by Salix to Lupin with respect to sales of products covered by Lupin
patents or jointly-held patents. Additionally, Salix will pay Lupin
minimum quarterly payments for product development and other
activities. Rifaximin is used in the treatment of traveller's diarrhoea and
hepatic encephalopathy, for which it received orphan drug status from
the USFDA in 1998.
Sun, Merck tie up to commercialise branded generic in emerging
markets
Sun Pharma and Merck's subsidiary MSD Pharmaceuticals have formed a
joint venture to develop, manufacture and commercialise branded
generics in emerging markets. Under the JV, Sun Pharma Advanced
Research Company (SPARC) will develop the product while Sun Pharma
will manufacture the drugs and Merck will register and market these
products in more than 100 emerging markets. Financial aspects and
selection of the product basket are yet to be decided by both companies.
The JV board can select the drugs that are in the development pipeline
of SPARC and specific products from Merck's portfolio.
Lupin signs patent license agreement with Abbott
Lupin and its subsidiaries have entered into a license agreement with US
based Abbott Laboratories and Laboratories Fournier SA for eight
patents on cholesterol-lowering drug Fenofibrate. The agreement
between the two parties also covered continuations, extensions, reissues,
re-examinations and so on. Fenofibrate was developed by
Groupe Fournier SA and acquired in 2005 by Solvay Pharmaceutical. In
late 2009, Solvay's pharma business was bought over by Abbott. Lupin
acquired Antara from bankrupt Oscient Pharmaceuticals Corp in
September 2009. Antara's patent expires in 2020. Abbott also sells a
version of fenofibrate under the brand name TriCor.
Other developments
Cipla seeks voluntary license for Isentress
Cipla has applied for a voluntary license for Merck’s Isentress stating that
the drugs is exorbitantly priced and is inaccessible to needy patients in
India. The drug Isentress is an HIV integrase inhibitor
Dr Reddy’s expands its R&D centre in Cambridge, United Kingdom
Dr Reddy’s Laboratories opened its newly expanded Chirotech
Technology Centre at Cambridge Science Park, UK where Chirotech has
been based for the last 20 years. The new 33,000 sq ft facility is purpose
built for laboratories and offices and has been fitted to Dr Reddy’s
specific requirements for chemistry, biology and analytics. The additional
capacity will facilitate an initial doubling of scientific staff in Chirotech
while providing for further capacity additions in future. It will help
strengthen core capabilities in biocatalysis and chemocatalysis, build
capabilities in fast growing segments like Activated mPEGs and peptides,
and allow development of other areas of expertise in chemistry and
processing for use in the pharmaceutical industry.
Elder Pharma plans manufacturing in Bulgaria for European market
Elder Pharma plans to start manufacturing up to six of its products at the
facility of its Bulgarian arm Elder Biomeda AD to market them in the
Europe market. The six products include products in women healthcare
and nutritional. To start with, the company plans to launch calcium
supplement Shelcal in the Bulgarian market. The company is also
planning to launch NeutraHealth product in the current fiscal.
No comments:
Post a Comment