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Friday, September 14, 2018

R&D Cooperation Between China and Western Pharma Companies Up 70%


Without a doubt China has become one of the most important markets for pharma companies, given the vast patient population and the rising cancer rates. And it seems that western pharmaceutical companies are making greater inroads there.
According to an August report in the Financial Times, since 2012 research and development cooperation between U.S. companies and China are up 70 percent. The Chinese biopharma market is booming as more and more companies eye breaking into that rich market. With that increase in cooperation, there has also been an increase in patent approval in China – but the majority of those have been made by western companies in the Chinese market or were made by Chinese universities without an eye for commercialization. A recent report by IAM, an organization that tracks intellectual property news, noted that Chinese biotech innovation “has yet to make its stamp on the global market.” But that may be slowly changing as companies like BeiGene and WuXi Apptec make inroads into the western markets.
Earlier this month, China’s BeiGene teamed up with SpringWorks Therapeutics to develop therapeutics that will target advanced solid tumors that contain RAS mutations, as well as other MAPK aberrations. BioSpace reported that the companies will combine BeiGene’s investigational RAF dimer inhibitor, lifirafenib (BGB-283) and SpringWorks Therapeutics’ investigational MEK inhibitor, PD-0325901 in patients with advanced solid tumors. The first Phase Ib trial is expected to begin in the first quarter of 2019.
That’s not the only good news that BeiGene has posted. Earlier this summer BeiGene reported positive preliminary topline results from its Phase II trial of tislelizumab, the company’s investigational checkpoint inhibitor for relapsed/refractory classical Hodgkin’s lymphoma (R/R cHL). BeiGene’s investigational Bruton’s tyrosine kinase (BTK) inhibitor zanubrutinib also snagged Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with Waldenström macroglobulinemia.
In August, WuXi’s subsidiary Shanghai SynTheAll Pharmaceutical Co., Ltd., a contract development and manufacturing organization, secured a physical toehold in the United States, opening an operation site in San Diego that will provide process research and development as well as API manufacturing services for early phase clinical studies.
Not only is WuXi establishing a toehold for its CRO, the company has formed several partnerships with U.S. companies, including through investments, such as startups like Unity Biotechnology and Ideaya Biosciences, Inc.  WuXi has also formed partnerships with western companies to do business in China. In April WuXi formed a partnership with Seattle-based Juno Therapeutics to develop treatments for cancer with the formation of a new Chinese company called JW Biotechnology Co., LtdThe new Chinese company’s mission will be to build a cell therapy company in China through using Juno’s chimeric antigen receptor (CAR) and T cell receptor (TCR) technologies in combination with WuXi AppTec’s R&D and manufacturing platform.
Juno isn’t the only company to grab its own toehold in China. In July, Roivant Sciences launched Sinovant Sciences in China with an aim at developing innovative treatments for some of China’s most pressing medical concerns.  The company launched with four therapies suitable for Phase III clinical trial application or registration in China, including Derazantinib, a fibroblast growth factor receptor (FGFR) inhibitor in Phase III development for the treatment of intrahepatic cholangiocarcinoma (iCCA), a form of liver cancer with high incidence in Greater China and no approved therapies globally.
Also in July, Takeda noted that its China program is its second-biggest business behind the United States. Takeda’s goal is to launch their medications in China as the same rate as they attempt in their other markets, including the U.S. and Europe. Takeda now regards China as a core country to its business practice.

Apple Watch more likely a positive for BioTelemetry, says Lake Street


After spending time with Joe Capper and Heather Getz, CEO and CFO of BioTelemetry (BEAT), Lake Street analyst Brooks O’Neil senses that Apple’s (AAPL) Watch Series 4, which includes a built-in electrocardiogram, is more likely a positive for BioTelemetry “than a buzzer sounding a flat-line for the company’s future.” BioTelemetry remains the leading cardiac monitoring company and this is likely to continue for the foreseeable future, O’Neil tells investors in a research note. He points out the company has a partnership with Apple in cardiac monitoring and with Sanofi (SNY) and Alphabet (GOOG) in diabetes. The analyst’s guesses that its partnership is one element giving BioTelemetry management comfort in evaluating the role Apple might play in the company’s future. O’Neil reaffirms a Buy rating on the shares with a $90 price target.
https://thefly.com/landingPageNews.php?id=2790691

Johnson & Johnson price target raised to $160 from $150 at Wells Fargo


Johnson & Johnson price target raised to $160 from $150 at Wells Fargo. Wells Fargo analyst Larry raised his price target for Johnson & Johnson to $160 after the company hosted an investor call to provide an update on its Pharmaceuticals business. The analyst heard no strategic change to the business saying J&J maintains focus on its six key therapeutic areas and remains agnostic to the source of innovation. While the company did not provide 2019 guidance, management’s tone came across as confident in the business outlook, Biegelsen tells investors in a research note. He keeps an Outperform rating on Johnson & Johnson.
https://thefly.com/landingPageNews.php?id=2790707

Bovie Medical initiated at Dougherty


Bovie Medical initiated with a Buy at Dougherty. Dougherty initiated Bovie Medical with a Buy $11 price target.
https://thefly.com/landingPageNews.php?id=2790729

FDA eyes US Smokeless Tobacco Modified Risk Tobacco Product application


U.S. Smokeless Tobacco, a wholly-owned subsidiary of Altria Group, announced that the FDA accepted and filed for substantive scientific review a Modified Risk Tobacco Product application for its moist smokeless tobacco product Copenhagen Snuff Fine Cut. The application requests FDA authorization to make one claim: “IF YOU SMOKE CONSIDER THIS: Switching completely to this product from cigarettes reduces risk of lung cancer.” The Agency will begin a substantive scientific review process, which includes opportunities for public comment.
https://thefly.com/landingPageNews.php?id=2790763

Principia Biopharma indicated to open at $26


Principia Biopharma priced 6.25M shares at $17.00. BofA/Merrill, Leerink and Wells Fargo acted as joint book running managers for the offering.
https://thefly.com/landingPageNews.php?id=2790771

InVitae (NVTA) Announces Chitra Nayak to Board


Invitae Corporation (NYSE: NVTA) announced the appointment of Chitra Nayak to its Board of Directors, effective September 10, 2018.
“We are pleased to welcome Chitra Nayak to our board of directors and look forward to working with her, taking full advantage of her considerable track record of helping companies achieve transformational growth to scale and innovate globally,” said Sean George, co-founder and chief executive officer of Invitae. “Chitra has deep operational and commercial leadership expertise in growing market share and strengthening industry leadership positions for rapidly growing companies, including organizations like ours that are transforming highly competitive industries. Her strong customer orientation and perspective will be a valuable addition to our board as we scale our business to bring genetic information into mainstream medical care.”
Nayak’s depth of knowledge in sales leadership, operations and product management was built during a variety of leadership roles with fast-growing organizations such as Salesforce.com, which grew from $300 million in revenue and 1,000 employees to $5 billion in revenue and 18,000 employees in the time she was with the company.
“Invitae’s focus on making medical genetics affordable and accessible has the potential to transform healthcare. The company is driving the emergence of a new industry, moving from the test-by-test approach of the past to the creation of a network that will allow patients to receive a faster diagnosis and better treatment because they have access to information about their genes,” said Nayak. “I’m happy to join the board at this exciting time and look forward to helping the team deliver on its mission to help improve healthcare for billions of people.”
Nayak has more than 25 years of professional experience in product management, sales leadership, general management and operations roles at various companies, having successfully built operational engines to enable these businesses to scale. Most recently she was COO running GTM at Comfy, Inc., a disruptive real-estate tech startup revolutionizing the way people interact with their workplaces. Prior to joining Comfy in 2017, Nayak served as chief operating officer of Funding Circle LTD from 2015 to 2016. From 2007 to 2015, Nayak served in several positions at Salesforce.com, Inc., including vice president of marketing strategy and operations from 2007 to 2008, senior vice president of global sales development from 2008 to 2013, and chief operating officer of platform from 2013 to 2015.
Nayak holds an M.B.A in Business Administration from Harvard Business School, an M.S. in Environmental Engineering from Cornell University, and a B.S. in engineering from Indian Institute of Technology.