Global Pharma Briefs: News from Asia and the USBy
A roundup of developments from India (Bayer, GSK), the US (Boehringer Ingelheim, Lilly, Tetraphase, Amicus), and Japan (Amgen).
Bayer, Curadev Sign Agreement To Develop STING Antagonists Program
Bayer and Curadev, a small-molecule drug-discovery company based in New Dehli, India, have formed a research collaboration and license agreement to discover new drug candidates for the treatment of lung diseases, cardiovascular diseases and other inflammatory disease.
The collaboration will use Curadev’s Stimulator of Interferon Genes (STING) antagonist program, which aims to discover and develop inhibitors of the intracellular STING pathway, which can modulate the immune response associated with various auto-inflammatory diseases. Under the agreement, Bayer will gain exclusive access to novel molecules from Curadev that are designed to inhibit the STING pathway. The companies will collaborate to optimize and advance these molecules as well as others generated during the collaboration into clinical development.
Under the agreement, Curadev will receive an upfront payment. In addition, Curadev will receive research funding during the research term and might be eligible for preclinical, clinical and sales milestones of potentially over EUR 250 million ($270 million) as well as royalties of single-digit percentages of net sales.
GSK Completes Divestment of Consumer Healthcare Brands in India to Unilever
GlaxoSmithKline has completed the divestment of its Horlicks brand rights, its malted milk drink brand, and other Consumer Healthcare nutrition products in India to the consumer products company, Unilever, including the merger of its Indian-listed entity, GlaxoSmithKline Consumer Healthcare Limited (GSK India), and Hindustan Unilever Limited (HUL). The transaction was previously announced in December 2018.
Through the merger of GSK India with HUL, GSK now holds a 5.7% stake in HUL, an Indian public company listed on the Indian National Stock Exchange and the Bombay Stock Exchange. GSK says it intends to monetize its holding in HUL at such time it considers appropriate by taking into account market conditions.
GSK says that India remains an important growth market for the company and that it is committed to investing in both its pharmaceuticals business and its over-the-counter and oral health brands in the country. As part of the transaction, HUL will distribute select Consumer Healthcare brands, Sensodyne, Crocin, Otrivin, and Eno, for GSK in India. GSK will continue to be responsible for demand generation, portfolio strategy, R&D and marketing for these brands.
GSK also completed the divestment of its Horlicks brands rights and other Consumer Healthcare nutrition products to Unilever in other markets for cash proceeds equivalent to £397 million ($492 million).
GSK said that the pending sale of its stake in GlaxoSmithKline Bangladesh is expected later this quarter, subject to local procedures.
In addition, GSK noted that GSK India is not part of the GSK Consumer Healthcare joint venture with Pfizer and the merger of GSK India and HUL therefore does not impact the joint venture. In 2019, Pfizer and GSK formed a joint venture in which the two companies combined their respective consumer healthcare businesses.
Amgen Establishes Wholly Owned Affiliate in Japan
Amgen has completed the purchase from Astellas of 49% of the shares of Amgen Astellas BioPharma K.K. (AABP), a joint venture between Amgen and Astellas established in 2013. AABP, which is now a wholly owned Amgen affiliate in Japan, was renamed Amgen K.K.
BI, Lilly Issued Complete Response Letter by FDA
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Boehringer Ingelheim and Eli Lilly and Company for their supplemental new drug application (sNDA) of empagliflozin 2.5 mg as an adjunct to insulin for adults with Type 1 diabetes.
The CRL indicates that the FDA is unable to approve the application in its current form, consistent with the outcome of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee in November (2019).
Empagliflozin was first approved by the FDA in 2014 to in doses of 10 mg and 25 mg as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes. In 2016, the FDA approved a new indication for the drug for reducing the risk of cardiovascular death in adult patients with Type 2 diabetes mellitus and cardiovascular disease.
The companies say that clinical trials have been initiated to evaluate the impact of empagliflozin on people living with heart failure or chronic kidney disease.
Empagliflozin is being developed as part of a diabetes-drug alliance between Boehringer Ingelheim and Lilly that the companies formed in January 2011.
AcelRx To Acquire Tetraphase Pharmaceuticals
AcelRx, a Redwood City, California-based specialty pharmaceutical company, has agreed to acquire Tetraphase Pharmaceuticals, a Watertown, Massachusetts-based biopharmaceutical company, in a stock-for-stock transaction.
Under the agreement, Tetraphase stockholders will receive, for each share of Tetraphase common stock, 0.6303 of a share of AcelRx common stock, valued at approximately $14.4 million as of the close of trading on March 13, 2020, and one contingent value right (CVR), which would entitle the holders to receive aggregate payments of up to $12.5 million for the achievement of future Xerava net sales milestones starting in 2021. Xerava is a tetracycline class antibacterial indicated for the treatment of complicated intra-abdominal infections in patients 18 years of age and older.
The transaction was unanimously approved by the boards of directors of both companies and select Tetraphase stockholders and warrant holders have signed voting agreements in favor of the transaction, which is expected to close in the second quarter of 2020.
Amicus Opens Research and Gene Therapy Center of Excellence
Amicus Therapeutics, a Cranbury, New Jersey-based biopharmaceutical company developing treatments for rare metabolic diseases, has opened a Global Research and Gene Therapy Center of Excellence in City Square in Philadelphia to advance its rare-disease gene-therapy programs.
In 2019, Amicus and the University of Pennsylvania (announced an expansion of their gene-therapy collaboration that provides Amicus with disease-specific worldwide rights to Penn’s gene-therapy technologies from the Wilson Lab for the majority of lysosomal storage disorders, as well as 12 additional more prevalent rare diseases, including Rett Syndrome, Angelman Syndrome, and select other muscular dystrophies.
The 75,000-square-foot center consists of offices and laboratories. It will ultimately house approximately 200 researchers and drug developers focused exclusively on gene therapies.
Source: Amicus Therapeutics