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G r owt h i n a c u t e t h e r a p i e s , a p l e a s a n t s u r p r i s e…
Indian pharma market witnessed strong growth of 21.5% YoY in
November 2011, which was higher than 13.7% YoY in October 2011, as
per latest All India Organisation of Chemists & Druggists (AIOCD) data.
We saw a sharp recovery in therapies like anti-infectives (17.9%), GI
(24.6%) and gynaecology (18.2%). These therapies were languishing
around single digit growth in the past few months. Extended monsoon
resulted in higher growth in anti-malarials to 20%. Companies like Pfizer
India (31.2%), Ipca Labs (30.2%), Sun Pharma (28.8%), Glenmark Pharma
(28.6%) and GSK Pharma (23.1%) registered robust growth during the
month. For the 12 months ending November 2011, the IPM grew by
14.9% compared to 14.5% in October 2011.
During the period, Ranbaxy launched the much awaited generic version
of Lipitor, the world’s largest selling brand. The mood was, however,
dampened by profit sharing agreement with Teva. Ranbaxy also signed a
consent decree with the USFDA to resolve the pending CGMP issues
with a provision of ~US$500 million.
On the approvals front, Strides once again hogged the limelight with
maximum number of approvals in the consecutive month, thanks to
speedier approvals from the USFDA in injectables category. Other
companies like Glenmark Pharma, Sun Pharma, and Torrent Pharma
received one approval each during the period.
On the R&D front, Glenmark received a setback when Napo Pharma, its
partner in the development of drug for HIV related Diarrhoea terminated
the contract due to lack of regulatory filing. Glenmark was supposed to
launch this product in 140 countries (excluding regulated market) by
2013.
A report published by US Government Accountability Office during the
month gave a detailed account on shortage of drugs in the US market
and issues related to shortage of drugs. The report indicates a 200%
increase in drug shortages between 2006 and 2011.
S e c t o r v i e w
During the month, the healthcare index managed to stay afloat on
account of some defensive buying. Market sentiments remained weak on
account of some really poor macro data, which led to hammering of
frontline stocks. The markets have also started weighing the impact of
currency fluctuation on pharma stocks. Companies like Sun, Divi’s, Cipla,
Biocon, Lupin and Ipca are well placed to reap the benefits of favourable
currency fluctuation on account of nil to very less component of forex
debt. On the other hand, players like Ranbaxy, Jubilant, Aurobindo,
Cadila, Glenmark and Strides will have to make substantial MTM
provisions for restatement of forex debts. Going ahead, we expect forex
to slowly become a major determinant if the pressure on the Indian
rupee persists. The sector, however, is still expected to outperform the
broader market on account of good traction from the US supported by
product approvals, a growing presence in Pharmerging markets and a
strong foothold in India.
Regulatory approvals
Aurobindo Pharma gets UKMHRA nod for hypertension drug
Aurobindo Pharma has received marketing approval from the UK
Medicines and healthcare products Regulatory Agency (UK MHRA) for
the Losartan Potassium Hydrochlorothiazide tablets in the multiple
strengths of 12.5 mg, 25 mg, 50 mg and 100 mg tablets. It is the generic
version of Merck’s Hyzaar and is used for the treatment of Hypertension.
The company has already received approval for the drug from USFDA.
Glenmark gets tentative nod for Montelukast sodium tablets
Glenmark has received tentative approval for Montelukast Sodium 10 mg
tablets from the USFDA. The drug is the generic version of Merck’s
Singulair tablets. The patent of the drug will be expiring in August 2012.
As per IMS Health, the annual sales of Singulair 10 mg tablets are around
US$3.2 billion. Singulair is indicated for prophylaxis and chronic
treatment of asthma in adults and paediatric patients 12 months and
older, for prevention of exercise-induced bronchoconstriction (EIB) in
patients 15 years and older, for relief of symptoms of seasonal allergic
rhinitis in patients two years and older and perennial allergic rhinits in
patients six months and older.
Sun gets USFDA nod for Tramadol HCL tablets
Sun Pharmaceutical Industries has received USFDA approval to market
Tramadol hydrochloride tablets. These tablets (100 mg, 200 mg and 300
mg) are therapeutically equivalent to Ultram ER tablets of Valeant
International. Tramadol tablets have annual sales of approximately
US$125 million in the US. These are indicated for management of
moderate to moderately severe chronic pain in adults who need aroundthe-clock treatment of their pain for an extended period of time.
Strides receives tentative nod for Oxaliplatin Injection
Strides Arcolab has received tentative approval for additional strength of
Oxaliplatin Injection. According to IMS data, the US market for
Oxaliplatin is approximately US$104 million. The company had earlier
received tentative approval for Oxaliplatin Injection, 5mg / mL, packaged
in 50 mg / 1mL, 100 mg/20 mL, and 200 mg/40mL single dose vials.
Strides gets USFDA nod for oncology injection Cytarbine Injection
Strides Arcolab has received USFDA approval for Cytarabine Injection 20
mg/ mL, packaged in 500 mg/ 25 mL Multiple-dose vials, 20 mg/ mL,
packaged in 100 mg/5 mL Single-dose vial and 20 mg/ mL, packaged in
1000 mg/ 50 mL pharmacy bulk packages. Cytarabine is an anti-cancer
chemotherapy drug. Cytarabine is used to treat different forms of
leukaemia, including acute and chronic myelogenous and acute
lymphocytic leukaemia. According to IMS data, the US market for
cytarabine is worth nearly US$12.3 million. Cytarabine is part of Strides'
oncology portfolio licensed to Pfizer in January, 2010, for the US market
and is expected to be launched shortly.
Ranbaxy gets USFDA approval for generic Lipitor
Ranbaxy Laboratories’ generic version of Pfizer Inc.’s $10.7 billion Lipitor
cholesterol pill was approved for US sale by the USFDA. Ranbaxy’s copy
of the world’s top-selling drug, known chemically as atorvastatin, will be
manufactured by the company’s Ohm Laboratories unit in New
Brunswick, New Jersey. Ranbaxy has 180 days exclusivity for the sale in
the US
IP issues, and R & D
Cipla to stop marketing two anti-flea products in the US
Bayer Healthcare LLC and Cipla have signed a settlement agreement to
stop selling products that infringe Bayer’s Advantage and Advantix
trademarks. Cipla markets similar kinds of products under the name DA
Double Advantage over various websites in the US market. Cipla will
stop marketing the product and also stop using trademark Advance for
animal products. The company had also agreed to recall any products
remaining in the sales pipeline.
Napo terminates agreement with Glenmark related to Crofelemer
Napo Pharmaceuticals has terminated its collaboration agreement with
Glenmark Pharmaceuticals dated July 2, 2005 related to developing and
commercialising rights of Crofelemer in over 140 countries and also
distributing through relief agencies in those countries. Napo terminated it
as Glenmark failed to file a single application for regulatory approval with
DCGI or any other regulatory agency.
Glenmark strongly denies that Napo has any basis for terminating the
collaboration agreement and Glenmark is seeking a declaration from an
arbitration panel that Napo's claims of breach are unfounded. On
December 9, 2011, Glenmark formally requested that the arbitration
panel issue an interim order directing Napo to comply with the
collaboration agreement during the pendency of the arbitration.
Deals & Alliances
Ranbaxy launches generic Lipitor in US market through Teva
Israel based Teva Pharmaceutical Industries has announced an
agreement with Ranbaxy Laboratories regarding Generic Lipitor.
Pursuant to the deal, Teva Pharmaceuticals US, Inc and Ranbaxy
Laboratories, a portion of the profits from Ranbaxy's sales of Atorvastatin
Calcium Tablets during Ranbaxy's 180-day first-to-file exclusivity period,
will be paid to Teva.
Orchid gets milestone payment from Merck
Orchid Chemicals & Pharmaceutical has received a milestone payment of
US$ 1.5 million from US based Merck & Co. The company received the
milestone payment as it completed pre-clinical trials for the anti-infective
drug. Both companies entered into an agreement in September 2008 to
focus on the discovery, development and commercialisation of new
drugs to treat bacterial and fungal infections.
Abbott to market Cadila products in emerging markets by 2013
As per the licensing agreement between Abbott and Cadila Healthcare
signed in June 2010, Abbott would be marketing Zydus products in 2013.
Abbott expects to market at least 25 products in 14 emerging markets by
2013. So far Cadila Healthcare has received | 47 crore as licensing
payment from Abbott.
New Launches
Ranbaxy launches generic Caduet in US market
Ranbaxy Laboratories has launched a generic version of Pfizer’s blood
pressure- and cholesterol-lowering drug Caduet in the US following an
agreement between the two companies. Caduet has annual sales of
US$339 million in the US.
Opto Circuits launches advanced cardiac diagnostic product in India
Opto Circuit’s subsidiary, Advanced Micronic Devices Ltd’s (AMDL)
healthcare division has launched the Cardiac Science family of advanced
cardiac diagnostic products in India. The products are to be sold under
the brands of Cardiac Science, Quinton, Burdick and Powerheart.
Facility Approval
Ranbaxy’s Mohali facility gets USFDA approval
The USFDA has given an approval for Ranbaxy's finished dosage plant in
Mohali. This is the first approval after the FDA banned Ranbaxy's plants
in Paonta Sahib and Dewas.
Fund Raising
Dr Reddy’s raises | 1077 crore in Q3FY12
Dr Reddy’s Laboratories has raised | 1077 crore of debt in the OctoberDecember quarter to meet working capital requirements and also for
refinancing old loans. It has raised the debt through its Switzerland
subsidiary from Citigroup Global Markets Asia.
Orchid raises US$100 million to repay FCCB debt
Orchid Chemicals and Pharmaceuticals Ltd (OCPL), has received sanction
of US$100 million by way of external commercial borrowings (ECBs)
from a consortium of Indian banks to redeem its outstanding foreign
currency convertible bonds (FCCBs), which falls due in February, 2012.
The ECBs and internal accruals would support the company to redeem
the outstanding FCCB of US$117 million along with the yield-to-maturity,
which would fall due in February, 2012. The total redemption value is
US$167 million.
Natco Pharma raises | 67 crore to fund future projects
Natco Pharma has raised | 67.4 crore through a QIP issue of 30 lakh
shares at | 225 per share. The funds will be used to part finance its
expansion plans. In a separate deal, Sun Pharmaceuticals promoter Dilip
Shanghvi has acquired a 3% stake in Natco Pharma for | 18.34 crore
from Orange Mauritius Investments at | 253 apiece.
Other development
Ranbaxy to provide US$500 million to resolve cGMP issues
Ranbaxy has reached an agreement with the USFDA to comply with US
manufacturing practices. Ranbaxy has said it would make a US$500
million provision to resolve potential criminal and civil liabilities arising
from an investigation by the US Department of Justice. The USFDA has
banned the import of Ranbaxy’s 30 generic formulations in 2008 from
Dewas and Paonta Sahib units, citing compliance issues.
Three injured in blast at Aurobindo’s intermediate facility
Three people were injured in an explosion at the powder processing area
of Aurobindo Pharma’s intermediate facility at Ranastalam of Srikakulam
district, Andhra Pradesh.
Government approves de-notification of Dr Reddy’s Medak SEZ
The government has approved the de-notification of Dr Reddy’s SEZ in
Medak, Andhra Pradesh. Earlier, the company requested the denotification of the Medak SEZ. Dr Reddy’s has API facility at Medak. The
company is planning to set up an API facility close to the formulation
facility, which is situated in the Vishakhapatnam SEZ. The company
would refund the duty benefits availed of the name of SEZ. DRL acquired
land of ~260 acres at both Medak and Vishakhapatnam SEZ. For setting
up the new API and manufacturing facility, it is expected to spend around
US$200 million.
India Equity Research Reports, IPO and Stock News
Visit http://indiaer.blogspot.com/ for complete details �� ��
G r owt h i n a c u t e t h e r a p i e s , a p l e a s a n t s u r p r i s e…
Indian pharma market witnessed strong growth of 21.5% YoY in
November 2011, which was higher than 13.7% YoY in October 2011, as
per latest All India Organisation of Chemists & Druggists (AIOCD) data.
We saw a sharp recovery in therapies like anti-infectives (17.9%), GI
(24.6%) and gynaecology (18.2%). These therapies were languishing
around single digit growth in the past few months. Extended monsoon
resulted in higher growth in anti-malarials to 20%. Companies like Pfizer
India (31.2%), Ipca Labs (30.2%), Sun Pharma (28.8%), Glenmark Pharma
(28.6%) and GSK Pharma (23.1%) registered robust growth during the
month. For the 12 months ending November 2011, the IPM grew by
14.9% compared to 14.5% in October 2011.
During the period, Ranbaxy launched the much awaited generic version
of Lipitor, the world’s largest selling brand. The mood was, however,
dampened by profit sharing agreement with Teva. Ranbaxy also signed a
consent decree with the USFDA to resolve the pending CGMP issues
with a provision of ~US$500 million.
On the approvals front, Strides once again hogged the limelight with
maximum number of approvals in the consecutive month, thanks to
speedier approvals from the USFDA in injectables category. Other
companies like Glenmark Pharma, Sun Pharma, and Torrent Pharma
received one approval each during the period.
On the R&D front, Glenmark received a setback when Napo Pharma, its
partner in the development of drug for HIV related Diarrhoea terminated
the contract due to lack of regulatory filing. Glenmark was supposed to
launch this product in 140 countries (excluding regulated market) by
2013.
A report published by US Government Accountability Office during the
month gave a detailed account on shortage of drugs in the US market
and issues related to shortage of drugs. The report indicates a 200%
increase in drug shortages between 2006 and 2011.
S e c t o r v i e w
During the month, the healthcare index managed to stay afloat on
account of some defensive buying. Market sentiments remained weak on
account of some really poor macro data, which led to hammering of
frontline stocks. The markets have also started weighing the impact of
currency fluctuation on pharma stocks. Companies like Sun, Divi’s, Cipla,
Biocon, Lupin and Ipca are well placed to reap the benefits of favourable
currency fluctuation on account of nil to very less component of forex
debt. On the other hand, players like Ranbaxy, Jubilant, Aurobindo,
Cadila, Glenmark and Strides will have to make substantial MTM
provisions for restatement of forex debts. Going ahead, we expect forex
to slowly become a major determinant if the pressure on the Indian
rupee persists. The sector, however, is still expected to outperform the
broader market on account of good traction from the US supported by
product approvals, a growing presence in Pharmerging markets and a
strong foothold in India.
Regulatory approvals
Aurobindo Pharma gets UKMHRA nod for hypertension drug
Aurobindo Pharma has received marketing approval from the UK
Medicines and healthcare products Regulatory Agency (UK MHRA) for
the Losartan Potassium Hydrochlorothiazide tablets in the multiple
strengths of 12.5 mg, 25 mg, 50 mg and 100 mg tablets. It is the generic
version of Merck’s Hyzaar and is used for the treatment of Hypertension.
The company has already received approval for the drug from USFDA.
Glenmark gets tentative nod for Montelukast sodium tablets
Glenmark has received tentative approval for Montelukast Sodium 10 mg
tablets from the USFDA. The drug is the generic version of Merck’s
Singulair tablets. The patent of the drug will be expiring in August 2012.
As per IMS Health, the annual sales of Singulair 10 mg tablets are around
US$3.2 billion. Singulair is indicated for prophylaxis and chronic
treatment of asthma in adults and paediatric patients 12 months and
older, for prevention of exercise-induced bronchoconstriction (EIB) in
patients 15 years and older, for relief of symptoms of seasonal allergic
rhinitis in patients two years and older and perennial allergic rhinits in
patients six months and older.
Sun gets USFDA nod for Tramadol HCL tablets
Sun Pharmaceutical Industries has received USFDA approval to market
Tramadol hydrochloride tablets. These tablets (100 mg, 200 mg and 300
mg) are therapeutically equivalent to Ultram ER tablets of Valeant
International. Tramadol tablets have annual sales of approximately
US$125 million in the US. These are indicated for management of
moderate to moderately severe chronic pain in adults who need aroundthe-clock treatment of their pain for an extended period of time.
Strides receives tentative nod for Oxaliplatin Injection
Strides Arcolab has received tentative approval for additional strength of
Oxaliplatin Injection. According to IMS data, the US market for
Oxaliplatin is approximately US$104 million. The company had earlier
received tentative approval for Oxaliplatin Injection, 5mg / mL, packaged
in 50 mg / 1mL, 100 mg/20 mL, and 200 mg/40mL single dose vials.
Strides gets USFDA nod for oncology injection Cytarbine Injection
Strides Arcolab has received USFDA approval for Cytarabine Injection 20
mg/ mL, packaged in 500 mg/ 25 mL Multiple-dose vials, 20 mg/ mL,
packaged in 100 mg/5 mL Single-dose vial and 20 mg/ mL, packaged in
1000 mg/ 50 mL pharmacy bulk packages. Cytarabine is an anti-cancer
chemotherapy drug. Cytarabine is used to treat different forms of
leukaemia, including acute and chronic myelogenous and acute
lymphocytic leukaemia. According to IMS data, the US market for
cytarabine is worth nearly US$12.3 million. Cytarabine is part of Strides'
oncology portfolio licensed to Pfizer in January, 2010, for the US market
and is expected to be launched shortly.
Ranbaxy gets USFDA approval for generic Lipitor
Ranbaxy Laboratories’ generic version of Pfizer Inc.’s $10.7 billion Lipitor
cholesterol pill was approved for US sale by the USFDA. Ranbaxy’s copy
of the world’s top-selling drug, known chemically as atorvastatin, will be
manufactured by the company’s Ohm Laboratories unit in New
Brunswick, New Jersey. Ranbaxy has 180 days exclusivity for the sale in
the US
IP issues, and R & D
Cipla to stop marketing two anti-flea products in the US
Bayer Healthcare LLC and Cipla have signed a settlement agreement to
stop selling products that infringe Bayer’s Advantage and Advantix
trademarks. Cipla markets similar kinds of products under the name DA
Double Advantage over various websites in the US market. Cipla will
stop marketing the product and also stop using trademark Advance for
animal products. The company had also agreed to recall any products
remaining in the sales pipeline.
Napo terminates agreement with Glenmark related to Crofelemer
Napo Pharmaceuticals has terminated its collaboration agreement with
Glenmark Pharmaceuticals dated July 2, 2005 related to developing and
commercialising rights of Crofelemer in over 140 countries and also
distributing through relief agencies in those countries. Napo terminated it
as Glenmark failed to file a single application for regulatory approval with
DCGI or any other regulatory agency.
Glenmark strongly denies that Napo has any basis for terminating the
collaboration agreement and Glenmark is seeking a declaration from an
arbitration panel that Napo's claims of breach are unfounded. On
December 9, 2011, Glenmark formally requested that the arbitration
panel issue an interim order directing Napo to comply with the
collaboration agreement during the pendency of the arbitration.
Deals & Alliances
Ranbaxy launches generic Lipitor in US market through Teva
Israel based Teva Pharmaceutical Industries has announced an
agreement with Ranbaxy Laboratories regarding Generic Lipitor.
Pursuant to the deal, Teva Pharmaceuticals US, Inc and Ranbaxy
Laboratories, a portion of the profits from Ranbaxy's sales of Atorvastatin
Calcium Tablets during Ranbaxy's 180-day first-to-file exclusivity period,
will be paid to Teva.
Orchid gets milestone payment from Merck
Orchid Chemicals & Pharmaceutical has received a milestone payment of
US$ 1.5 million from US based Merck & Co. The company received the
milestone payment as it completed pre-clinical trials for the anti-infective
drug. Both companies entered into an agreement in September 2008 to
focus on the discovery, development and commercialisation of new
drugs to treat bacterial and fungal infections.
Abbott to market Cadila products in emerging markets by 2013
As per the licensing agreement between Abbott and Cadila Healthcare
signed in June 2010, Abbott would be marketing Zydus products in 2013.
Abbott expects to market at least 25 products in 14 emerging markets by
2013. So far Cadila Healthcare has received | 47 crore as licensing
payment from Abbott.
New Launches
Ranbaxy launches generic Caduet in US market
Ranbaxy Laboratories has launched a generic version of Pfizer’s blood
pressure- and cholesterol-lowering drug Caduet in the US following an
agreement between the two companies. Caduet has annual sales of
US$339 million in the US.
Opto Circuits launches advanced cardiac diagnostic product in India
Opto Circuit’s subsidiary, Advanced Micronic Devices Ltd’s (AMDL)
healthcare division has launched the Cardiac Science family of advanced
cardiac diagnostic products in India. The products are to be sold under
the brands of Cardiac Science, Quinton, Burdick and Powerheart.
Facility Approval
Ranbaxy’s Mohali facility gets USFDA approval
The USFDA has given an approval for Ranbaxy's finished dosage plant in
Mohali. This is the first approval after the FDA banned Ranbaxy's plants
in Paonta Sahib and Dewas.
Fund Raising
Dr Reddy’s raises | 1077 crore in Q3FY12
Dr Reddy’s Laboratories has raised | 1077 crore of debt in the OctoberDecember quarter to meet working capital requirements and also for
refinancing old loans. It has raised the debt through its Switzerland
subsidiary from Citigroup Global Markets Asia.
Orchid raises US$100 million to repay FCCB debt
Orchid Chemicals and Pharmaceuticals Ltd (OCPL), has received sanction
of US$100 million by way of external commercial borrowings (ECBs)
from a consortium of Indian banks to redeem its outstanding foreign
currency convertible bonds (FCCBs), which falls due in February, 2012.
The ECBs and internal accruals would support the company to redeem
the outstanding FCCB of US$117 million along with the yield-to-maturity,
which would fall due in February, 2012. The total redemption value is
US$167 million.
Natco Pharma raises | 67 crore to fund future projects
Natco Pharma has raised | 67.4 crore through a QIP issue of 30 lakh
shares at | 225 per share. The funds will be used to part finance its
expansion plans. In a separate deal, Sun Pharmaceuticals promoter Dilip
Shanghvi has acquired a 3% stake in Natco Pharma for | 18.34 crore
from Orange Mauritius Investments at | 253 apiece.
Other development
Ranbaxy to provide US$500 million to resolve cGMP issues
Ranbaxy has reached an agreement with the USFDA to comply with US
manufacturing practices. Ranbaxy has said it would make a US$500
million provision to resolve potential criminal and civil liabilities arising
from an investigation by the US Department of Justice. The USFDA has
banned the import of Ranbaxy’s 30 generic formulations in 2008 from
Dewas and Paonta Sahib units, citing compliance issues.
Three injured in blast at Aurobindo’s intermediate facility
Three people were injured in an explosion at the powder processing area
of Aurobindo Pharma’s intermediate facility at Ranastalam of Srikakulam
district, Andhra Pradesh.
Government approves de-notification of Dr Reddy’s Medak SEZ
The government has approved the de-notification of Dr Reddy’s SEZ in
Medak, Andhra Pradesh. Earlier, the company requested the denotification of the Medak SEZ. Dr Reddy’s has API facility at Medak. The
company is planning to set up an API facility close to the formulation
facility, which is situated in the Vishakhapatnam SEZ. The company
would refund the duty benefits availed of the name of SEZ. DRL acquired
land of ~260 acres at both Medak and Vishakhapatnam SEZ. For setting
up the new API and manufacturing facility, it is expected to spend around
US$200 million.
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