India terms US 'Special 301' process

India has termed the recently released United States Trade Representative (USTR) 2014 “Special 301 Report” a unilateral measure taken by the US to increase Intellectual Property Rights (IPR) protection beyond the TRIPS Agreement.

“The Special 301 process is a unilateral measure taken by the United States under their Trade Act, 1974 to create pressure on countries to increase IPR protection beyond the TRIPS Agreement. It is an extra territorial application of the domestic law of a country and is not tenable under the overall WTO regime”, Union Minister for Commerce & Industry Nirmala Sitharaman said.

India has a well-established legislative, administrative and judicial framework to safeguard Intellectual Property Rights which meets its obligations under the Agreement on Trade Related Intellectual Property Rights (TRIPS) while utilizing the flexibilities provided in the international regime to address its developmental concerns, the minister in a written reply said in Rajya Sabha on July 30.

AstraZeneca to acquire rights to Almirall's respiratory

AstraZeneca has entered an agreement to transfer to the company the rights to Almirall’s respiratory franchise for an initial consideration of $875 million on completion, and up to $1.22 billion in development, launch, and sales-related milestones. AstraZeneca has also agreed to make various sales-related payments.

Upon completion of the transaction, AstraZeneca will own the rights for the development and commercialisation of Almirall’s existing proprietary respiratory business, including rights to revenues from Almirall’s existing partnerships, as well as its pipeline of investigational novel therapies. The franchise includes Eklira (aclidinium); LAS40464, the combination of aclidinium with formoterol which has been filed for registration in the EU and is being developed in the US; LAS100977 (abediterol), a once-daily long-acting beta2-agonist (LABA) in phase II; an M3 antagonist beta2-agonist (MABA) platform in pre-clinical development (LAS191351, LAS194871) and phase I (LAS190792); and multiple pre-clinical programmes. Under the agreement, Almirall Sofotec, an Almirall subsidiary focused on the development of innovative proprietary devices, will also transfer to AstraZeneca.

Pfizer net earnings dips by 79% in Q2 to $2,912 million

Pfizer Inc, a second largest pharmaceutical company in the world after Novartis, has suffered heavy setback during the second quarter ended June 2014 on account of one time income received from sell of animal health business, Zoetis Inc.,  for a consideration of $10.4 billion in the last period. The net profit declined by 79.3 per cent to $2,912 million from $14,095 million in the corresponding quarter of last year. Its revenues also declined by 1.5 per cent to $12,773 million from $12,973 million due to multi-source generic competition for Celebrex in the US and destocking by wholesaler and retailer.

The company began managing its commercial operations through a new global commercial structure consisting of three operating segments viz., Global Innovative Pharmaceuticals Segment (GIP), Global Vaccines, Oncology and Consumer Healthcare segment (VOC) and Global Established Pharmaceutical segment (GEP).

KaloBios regains rights to KB001-A

KaloBios Pharmaceuticals, has recently provided an update on the status of the KB001-A development programme, including an update on its KB001-A collaboration with Sanofi Pasteur.

KaloBios has reached an agreement with Sanofi Pasteur to regain all rights to KaloBios' KB001-A programme. Under this agreement, the collaboration and licencing agreement entered into in 2010 has been terminated. Under that collaboration agreement, Sanofi Pasteur had been developing KB001-A, a patented monoclonal antibody targeting Pseudomonas aeruginosa (Pa), for Pa pneumonia prevention in the intensive care setting while KaloBios had been developing KB001-A for chronic treatment of Pa lung infections in cystic fibrosis (CF) patients.

Novartis net up by 3% to $3,283 million in Q2

Novartis International AG has posted marginal growth in profits as well as sales during the second quarter ended June 2014 due to lower sales of Diovan in Japan and US. Its net profit moved up by 3 per cent to $3,283 million from $ 3,188 million in the similar period of last year. Its net sales improved marginally by 2 per cent to $14,637 million from $14,637 million. EPS worked out to $1.24 as against $1.29 in the last period.

The major products like Gilenya, Afinitor, Tasigna, Galvus, Lucentis, Xolair, the COPD portfolio and Jakavi contributed 42 per cent of of pharmaceutical division sales as compared to 36 per cent in the last period. Sales growth was impacted by Japan, which saw a continued decline in Diovan sales and biennial price cut for many brands. US sales of Diovan impacted due to inventory destocking ahead of the generic entry in July 2014.

Alcon net sales improved 3 per cent in second quarter ended June 2014 due to growth in ophthalmic pharmaceuticals and surgical, coupled with strong emerging growth markets performance. The sales of Sandoz division increased by 19 per cent to $ 2.3 billion, as volume growth of 11 percentage points more than compensated for u percentage points of price erosion. However, Asia (excluding Japan) delivered double-digit sales growth.

Strides invests in Oncobiologics

Strides Arcolab has now made a strategic investment in Oncobiologics Inc, which is a privately held New Jersey-based biopharmaceutical firm developing a pipeline of biosimilars and next generation bio-therapeutics. The financial details have not been  disclosed.

According to the Bengaluru-based Strides, the investment is part of its efforts to fund promising bio-pharma companies with high quality scientific management and proprietary approaches to developments that confer significant time and cost advantages.

“The investments by Strides Arcolab represent important milestones for Oncobiologics.  The company is a long-term strategic partner that provides both financial strength and a proven track-record of successful business ventures.  We look forward to their support and guidance as we continue to execute Oncobiologics’ business and technical plans,” said Dr Pankaj Mohan, Founder & CEO, Oncobiologics.

Cell Act Pharma' CAP7.1 to treat biliary tract cancers

The Committee for Orphan Medicinal Products of the European Medicines Agency (EMA) has granted orphan drug designation to CellAct Pharma’s CAP7.1, an adapted version of the well-established anticancer agent etoposide, for the treatment of biliary tract cancers. European Union(EU) orphan drug designation is given to products for the diagnosis, prevention or treatment of rare diseases that are life-threatening or very serious. A disease is defined as rare in the EU if it affects fewer than five in 10,000 people.

Biliary tract cancer affects approximately 1.7 in 10,000 people in the EU. This is equivalent to a total of around 87,000 people. The granting of EU orphan drug designation provides CellAct with development and commercial incentives, including a 10-year period of market exclusivity, access to a centralised review process, protocol assistance and scientific advice during product development, waiving or reduction of certain fees, and eligibility for grants and R&D support initiatives.

CellAct is currently recruiting patients for a randomised, multicentre, proof-of-concept phase 2 study with CAP7.1in adults with refractory biliary tract carcinomas in Germany (www.cap7-1.com).