Novartis swaps three mid stage clinical assets with Mereo BioPharma

Novartis, a global healthcare company, announced a swap of clinical assets for equity with Mereo BioPharma Group Ltd. The deal involves compounds in areas of unmet medical need including BPS-804, to improve bone density in brittle bone syndrome, an orphan disease; BCT-197 for acute exacerbations in COPD, and BGS-649 for obese men with hypogonadotrophic hypogonadism to normalize testosterone levels.

Under the terms of the agreement, Novartis will have an equity stake in Mereo and will share in the success of the development of these compounds, including a share on milestones and royalties on future commercial sales.

Merck net profit dips by 66% to $688 million in Q2

Merck has received major setback during the second quarter ended June 2015 due to acquisitions, divestitures and foreign exchange. Its net profit declined sharply by 66 per cent to $687 million from $2,004 million in the corresponding period of last year. Its sales also declined by 11 per cent to $9,785 million from $10,934 million on account of lower sales in cardiovascular and hepatitis C portfolios. With lower profit, its EPS declined to $0.24 from $0.68 in the last period. R&D expenditure increased slightly to $1,670 million from $1,664 million.

Kenneth C Frazier, chairman and chief executive officer, said, “We're investing resources to grow our strongest brands and to support the most promising assets in our pipeline, while at the same time lowering our cost base and delivering operation leverage. We have made significant progress this quarter in two of our most important assets, the Keytruda and hepatitis C programmes, and will be fully prepared to take advantage of these potentially breakthrough opportunities. We are witnessing the introduction of breakthrough therapies for some of the most difficult-to-treat diseases.”

Its pharmaceutical sales declined by 6 per cent to $8,564 million from $9,098 million and that of animal health by 4 per cent to $840 million from $872 million. The company divested its consumer care business. The sales of cardiovascular portfolio of Zetia and Vytorin in US declined due to loss of exclusivity and that of Remicade, a treatment for inflammatory diseases, due to loss of exclusivity in Europe. Zetia sales declined $635 million from $717 million and that of Vytorin went down to $320 million from $417 million. Remicade sales declined to $455 million from $607 million.

Genzyme to buy AstraZeneca's rare disease medicine Caprelsa for $300 million

AstraZeneca, a global, innovation-driven biopharmaceutical business, has entered into a definitive agreement with Genzyme to divest Caprelsa (vandetanib), a rare disease medicine.

Caprelsa was granted Orphan Drug Designation by the US FDA in 2005 and is currently available in 28 countries for the treatment of aggressive and symptomatic medullary thyroid carcinoma, with global product sales of $48 million in 2014.

Under the terms of the agreement, Genzyme will pay AstraZeneca up to $300 million, including an upfront payment of $165 million to acquire the global rights to sell and develop Caprelsa, and further development and sales milestone payments of up to $135 million. The transaction does not include the transfer of any AstraZeneca employees or facilities. As an asset divestment, upfront receipt and any subsequent payments will be reported in Other Operating Income in the company’s financial statements.

Luke Miels, executive vice president, global product & portfolio strategy and corporate affairs, AstraZeneca, said: “Caprelsa is a rare disease therapy and the divestment to Genzyme, an expert leader in endocrinology, demonstrates our commitment to ensure patients continue to have access to this medicine while we sharpen our focus on key disease areas.”

Yara and BASF to set up $600-mn ammonia plant in Texas

Norwegian firm Yara International ASA and Germany-based BASF have agreed to set up an ammonia plant at the BASF site in Freeport, Texas, involving an investment of $ 600 million. As part of the project, Yara will build an ammonia tank at the BASF terminal and BASF will upgrade its current terminal and pipeline assets for the export of ammonia from the new plant - which is expected to come online in 2017.
 
"I am very pleased to be here today, initiating the construction of an important investment for Yara - alongside our partners at BASF. The building of the Freeport ammonia plant is a firm demonstration of how we deliver on our growth strategy," said Torgeir Kvidal, president and CEO of Yara, while attending groundbreaking ceremony for the new ammonia plant.

The plant will have a capacity of about 750,000 metric tonnes per year and will be owned 68 percent by Yara and 32 percent by BASF. Each party will off-take ammonia from the plant in accordance with its equity share. BASF will use its share of ammonia from the plant to produce caprolactam, a key ingredient in the manufacture of nylons for carpet, textiles, film, monofilaments, and wire and cable. Yara will market the remainder mostly to industrial customers in North America, in addition to supplying the agricultural sector.

Chimerix reports positive results from brincidofovir study

Chimerix, Inc., a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, announced that its investigational antiviral brincidofovir showed a survival benefit in a pivotal study of an animal model for smallpox.

Chimerix is developing brincidofovir as a medical countermeasure against smallpox, for which there is no antiviral agent currently approved. Brincidofovir has demonstrated broad-spectrum in vitro activity across five families of DNA viruses, and in addition to smallpox, is also being studied in two phase 3 clinical trials for prevention of cytomegalovirus (CMV) and treatment of adenovirus infections in immunocompromised patients. The US Food and Drug Administration (FDA) has granted Fast Track status to brincidofovir for smallpox, CMV, and adenovirus.

The pivotal smallpox study was conducted under the FDA's Animal Efficacy Rule, which allows for testing of investigational compounds in animal models to support the drug's effectiveness in diseases which are not ethical or feasible to study in humans. The primary objective of this study was to assess the efficacy of immediate and delayed treatment with brincidofovir after clinical signs of disease compared with placebo in preventing mortality in rabbits infected with the lethal rabbitpox virus - a well-characterized model of smallpox. The study met its primary endpoint.

Rabbits treated with brincidofovir upon the first clinical sign of disease, and rabbits that received brincidofovir 24 or 48 hours after the first clinical sign of disease, demonstrated a statistically significant (p < 0.05) reduction in mortality compared to rabbits that received placebo. Final results from this study, including data on the incidence and severity of clinical and laboratory events in each cohort, are expected by the fourth quarter of 2015 and will be submitted to an upcoming medical conference and to the FDA for discussion of next steps.

Sigma-Aldrich receives ISO 13485 certification

Sigma-Aldrich Corporation, a leading life science and high technology company, has received ISO 13485 certification for expanded quality assurance capabilities at its Dekalb and Barton facilities located in St. Louis.

The certification extends Sigma-Aldrich's ability to manufacture and offer critical raw materials, such as enzymes, proteins and antibodies used in diagnostic assays, and provides in vitro diagnostic (IVD) customers with industry-leading assurance of consistent quality to meet and exceed their supply chain needs at a time of increased regulatory requirements.

The Dekalb site, which manufactures enzymes and proteins, achieved the ISO 13485 certification following significant investments in production and packaging facilities as well as personnel training. A similar commitment to invest in capabilities for the diagnostics customer segment enabled ISO 13485 certification of quality management systems at the state-of-the-art Barton distribution warehouse, that can now serve as a central North American distribution center for Sigma-Aldrich raw materials designed for use in IVD manufacturing applications. These two St. Louis-based sites join the growing roster of ISO 13485 certified facilities located in Jerusalem and Rehovot (Israel, obtained in Q4 of 2014), which manufacture antibodies and enzymes, as well as the St. Louis Ewing site, which provides OEM assay manufacturing services to diagnostic customers.

As one of the leading suppliers of raw materials to the diagnostic market, Sigma-Aldrich made an investment to extend its ISO 13485 certification based on the company's assessment of clients' current and future needs. Sigma-Aldrich continually invests in quality assurance initiatives and has 44 Quality Control laboratories worldwide, as well as approximately 800 employees within the Sigma-Aldrich Quality organisation.

Pfizer plans to close its 50-year old Thane facility in September

Pfizer, a Rs. 1,800 crore plus pharma MNC after merging Wyeth, has decided to shut down its over 50 years Thane facility from September 16, 2015. The decision to close the site is based on an assessment its long term viability and its ability to achieve the needed production. There has practically been no production activity at this plant since 2013, and the closure will not impact the supply of any of our medicines to patients.

The company had offered a generous voluntary retirement scheme (VRS) to the workmen at this site last year, upon their request. This was taken up by as many as 132 of the 212 workmen. The remaining 80 workmen have continued to receive full wages, despite plant inactivity. As a part of the closure process, the company will honour its obligations towards requisite compensation, as mandated by law, for the remaining workmen. We are grateful for the contribution of the workmen and colleagues and will ensure that they are treated with fairness and respect.

Pfizer remains committed to providing high quality medicines to our patients and customers in India.