Pharmaceuticals Newsletter - 01 April to 05 April, 2013
Cardiac Science, an Opto Circuits group company, signed a definitive agreement on 29th March 2013 to sell its Diagnostic Cardiology product line to Mortara Instrument, Inc. for an estimated consideration of USD 21mn.
SC rejects Novartis' Glivec patent plea
The Supreme Court has rejected Novartis' Glivec patent plea. Upholding the Tribunal, Patent body order on the cancer treatment drug; it said the drug is not eligible for patent in India.
Novartis will also have to pay cost for filing the case. The company had argued that the molecule imatinib, on which Glivec is based, required years of research and modification to make it an effective, safe leukemia treatment. The drug is Novartis' top seller clocking in sales of $4.7 billion last year.
Calling the case 'not maintainable', the apex court said repetitive patents are not permissible on the same drug.
Post the Court ruling, Novartis India shares plummeted 5.5%. It is currently (11 AM) trading down 4.38% at Rs 572 per share on the Bombay Stock Exchange.
In 2006, the Indian Patent Office had denied patent to the company which was upheld by the Indian Intellectual Property Appellate Board.
Commenting on the judgement, Novartis said it was never granted an original patent for Glivec. "We believe original innovation should be recognised."
The stock traded in a range of Rs.558.10-Rs.604.80 in the intraday trade at BSE on Monday. Total traded quantity at the counter stood at 1.46lakh.
Merck v/s Glenmark
Merck Sharp & Dohme has filed a suit in the Delhi High Court against Glenmark for violating its patents on diabetes drugs Januvia and Janumet, says report.
“We are disappointed with Glenmark’s decision to introduce products that directly infringe upon our intellectual property rights (IPR), "MSD reported.
According to reports, Glenmark has maintained that its products — Zita and Zita-Met are branded generics launched after due diligence.
“Glenmark is a responsible company and has launched the products after due diligence and research, " the company was quoted as saying.
Piramal Group plans to sell Vodafone stake: reports
Piramal Healthcare is planning to offload its 11% stake in Vodafone India, according to reports.
Piramal Group Chairman Ajay Piramal reported "We had invested in Vodafone and it was a 24-36-month exit plan. We are still on track for that and we will exit either sometime this year or next,".
The company plans to invest in Vodafone for the short term because of strong growth prospects, says report.The company was expecting 17-20% return in around 18 months.
Dr Reddy appoints GV Prasad as chairman
Dr. Reddy's Laboratories Ltd. announced that based on the recommendations of the Nomination, Governance and Compensation Committee, its Board of Directors have appointed GV Prasad, presently Vice-Chairman and CEO as the "Chairman and CEO" and Satish Reddy as "Vice-Chairman" in addition to his present role of Managing Director and COO, effective from 30 March, 2013.
All other terms and conditions of their respective appointments like remuneration, tenure etc., as approved by the shareholders at their General Meetings remains the same.
Opto Circuits rationalizes its product offering by spinning off its Diagnostic Cardiology product line
Cardiac Science, an Opto Circuits group company, signed a definitive agreement on 29th March 2013 to sell its Diagnostic Cardiology product line to Mortara Instrument, Inc. for an estimated consideration of USD 21mn. The transaction does not include MySense, the novel, wearable, single-patient ECG recorder system and the Resuscitation business unit that markets automated external defibrillators (AEDsJ worldwide.
"Divestiture of the Diagnostic Cardiology product line will bring more strategic focus to Cardiac Science. The company will now be able to exclusively focus on innovation and the expansion of market share in its high-margin and high growth Resuscitation Business," said Neal Long, CEO, Cardiac Science.
"The addition of these businesses to our organization represents a marked opportunity to accelerate the introduction of Mortara's leading ECG technology to new markets," commented Dr. Justin Mortara, CEO.
AstraZeneca’s biologics unit, acquires AlphaCore Pharma
AstraZeneca announced that MedImmune, its global biologics research and development unit, has acquired AlphaCore Pharma, an Ann Arbor, Michigan-based biotechnology company focused on the development of ACP-501, a recombinant human lecithin-cholesterol acyltransferase (LCAT) enzyme.
LCAT, an enzyme in the bloodstream, is a key component in the reverse cholesterol transport (RCT) system, which is thought to play a major role in driving the removal of cholesterol from the body and may be critical in the management of high-density lipoprotein (HDL) cholesterol levels. The LCAT enzyme could also play a role in a rare, hereditary disorder called familial LCAT deficiency (FLD) in which the LCAT enzyme is absent.
Cardiovascular and metabolic disease is a core therapy area for AstraZeneca’s small and large molecule research.
"As the science in this area continues to evolve, we are committed to exploring unique pathways that could lead to new combination or standalone therapies for patients living with chronic and acute cardiovascular diseases,” said Dr. Bahija Jallal, Executive Vice President, MedImmune.
Ranbaxy resumes supply of Atorvastatin tablets in US
Ranbaxy Laboratories has resumed supply of Atorvastatin tablets to the US market. The company said in a filing with the Bombay Stock Exchange.
Piramal Ent, Tata Memorial Centre in cancer research pact
Piramal Enterprises Limited (PEL) and Tata Memorial Centre (TMC) announced that they will collaborate to enable the development of valuable tools to better understand disease biology and predict responses to various treatments for cancer patients.
The new alliance between the two organizations will focus on the development of preclinical cancer models to enhance the understanding of disease biology, treatment response/resistance and biomarkers as they relate to diagnosis, prognosis and response to drugs.
These models will be based on tumor tissues from cancer patients and are predicted to have better translational relevance than the currently used human cancer cell line models. Scientists at TMC and PEL hope to gain a better understanding of the mechanisms through which various drugs work on different cancers. This research could lead to new therapies and predict the medicine best suited to treat an individual cancer patient.
"Our collaboration with Piramal Enterprises addresses a critical need in cancer care, which is widely accessible and cost effective personalized medicine for cancer patients," said Dr Rajendra Badwe, M.D., Director of Tata Memorial Centre. Read more…
Aurobindo Pharma gets nod for Efavirenz tablets
Aurobindo Pharma Limited has announce that it is one of the first generics company to have received the tentative approval to manufacture and market its anti-AIDS combination drug Efavirenz / Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 600mg/200mg/300mg from the US Food & Drug Administration (USFDA).
Efavirenz / Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 600mg/200mg/300mg is the generic equivalent of Gilead Sciences Inc’s Atripla Tablets 600mg/200mg/300mg and falls under the Anti-Retroviral (ARV) segment. It is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.
This ANDA was reviewed under the expedited provisions of the President’s Emergency Plan for AIDS relief (PEPFAR).
Aurobindo now has a total of 182 ANDA approvals (156 Final approvals including 2 from Aurolife Pharma LLC and 26 Tentative approvals) from USFDA.
Dr. Reddy’s announces the launch of new injection in US
Dr. Reddy’s Labs announced the launch of Zoledronic Acid Injection in the US market. The injection is the generic version of Reclast, which got United States Food and Drug Administration, is a single use vial for intravenous infusion
eHealth Access uses tech to bridge rural health gap
e Health Access, a pioneer in healthcare technology which is on a constant strive to provide solutions for health care management, conducted a medical camp in the Dang district of Gujarat. The medical camp was a pilot test which offered free consultations with Doctors via the recently launched Medical Kiosk by eHealth Access.
The two day pilot started with Gujarat Dang district where 128 consultations (65% females and 35% male) were conducted successfully.
“This is a boon to rural India and can be a means to make Government of India’s Universal Health Program a reality, where we can reduce the doctors to Patient gap and make “doctor-reach” a reality for the common and underserved population, thereby aiding in the process of making India Healthy.” Said, Mr. Ram Prabhu, Techology Director, eHealth Access. “We started the pilot test in Gujarat and are planning replicate this activity PAN India.” He added.
The latest census of health sector shows that India is lagging behind in doctor- patient ratio. It is observed, at present, that there is only one doctor available for more than 1900 patients. Experts believe that in-order to reach an ideal doctor-patient ratio a standard, India has to wait till 2050. Read more…
'Novartis verdict to prevent abusive patenting of medicines'
The landmark decision by the Indian Supreme Court in Delhi to uphold India's Patents Act in the face of the seven-year challenge by Swiss pharmaceutical company Novartis is a major victory for patients' access to affordable medicines in developing countries, the international medical humanitarian organisation Doctors without Borders/Médecins Sans Frontières (MSF) stated.
“This is a huge relief for the millions of patients and doctors in developing countries who depend on affordable medicines from India, and for treatment providers like MSF," said Dr Unni Karunakara, MSF International President. “The Supreme Court's decision now makes patents on the medicines that we desperately need less likely. This marks the strongest possible signal to Novartis and other multinational pharmaceutical companies that they should stop seeking to attack the Indian patent law.”
India began granting patents on medicines to comply with international trade rules, but designed its law with safeguards – including a clause known as Section 3(d) -that prevent companies from abusing the patent system. Section 3(d) prevents companies from gaining patents on modifications to existing drugs, in order to ever extend monopolies.
Novartis first took the Indian government to court in 2006 over its 2005 Patents Act because it wanted a more extensive granting of patent protection for its products than offered by Indian law. In a first case before the High Court in Chennai, Novartis claimed that the Act did not meet rules set down by the World Trade Organization and was in violation of the Indian constitution. Novartis lost this case in 2007, but launched a subsequent appeal before the Supreme Court in a bid to weaken the interpretation of the law and empty it of substance. All of Novartis's claims have been rejected by the Supreme Court. Read more…
Sanovi announces appointments to its Advisory Board
Sanovi Technologies, the market leader in IT Disaster Recovery Management (DRM) software today announced the appointment of Mr. Vic Mahadevan and Dr. A. L. Rao to its Advisory Board. Mr. Vic Mahadevan was previously chief strategy officer at NetApp, and has over 25 years of senior level strategic planning and marketing experience.Dr. A L Rao was previously chief operating officer of Wipro Technologies, and has over 35 years of executive strategic planning, delivery and technology experience.
In his earlier role as Chief Strategy Officer for NetApp.Vic was responsible for leading NetApp's business strategy and identifying additional market and product opportunities to fuel future growth. Vic was also responsible for driving acquisitions, and supporting NetApp’s strategic alliances.
Before joining NetApp, Vic served as vice president of marketing for LSI Corporation, where he was responsible for product management, outbound marketing and business alliances. Earlier he served as CEO of leading storage and systems management companies Deeya Energy, NeoEdge Networks and MaXXan Systems (now CiperMax). Vic also served in senior management positions at BMC Software, Compaq and Ivita during his early years.
India’s SC rejects Glivec Patent, a credit negative for branded drug coms: Moody's
On 1 April, India’s Supreme Court rejected a patent application from Novartis AG (Aa3 stable) for its cancer drug Glivec on the grounds that the new drug was not sufficiently distinct from an earlier version to warrant patent protection. The landmark ruling by India’s highest court will not have a significant financial effect on Novartis, but it is credit negative for international branded pharmaceutical companies because it indicates that obtaining patent protection in India is likely to be more difficult than in other countries, which will increase the risk of generic competition. However, the decision is unlikely to deter international branded drug companies from further developing in the Indian market, given its growth prospects.
Because more than 95% of patients taking Glivec in India already get the drug for free under Novartis’ patient assistance programme, the financial effects on the company are minimal. In addition, the new patent law India adopted in 2005 contains a grandfathering clause that allows generic copies of drugs launched before 1995, which includes Glivec, to continue to be sold on the market.
However, the court ruling sets a negative precedent for the branded pharmaceutical industry because Glivec has been granted patent protection rights elsewhere in the world, indicating that other branded drug companies may find it challenging to secure patents in India owing to the country’s apparently narrower legal definition of what constitutes a novel, or innovative, product.
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