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Monday, February 3, 2020

Analyst action, Feb. 3

Bluebird bio (NASDAQ:BLUE) initiated with Buy rating and $120 (56% upside) price target at Bank of America. Upgraded to Outperform with a $100 price target at Evercore ISI. Shares up 2% premarket.
Centene (NYSE:CNC) initiated with Outperform rating and $90 (43% upside) price target at Evercore ISI. Shares up 1% premarket.
Myovant Sciences (NYSE:MYOV) initiated with Neutral rating and $15 (18% upside) price target at Citigroup.
Merit Medical Systems (NASDAQ:MMSI) upgraded to Outperform with a $43 (18% upside) price target at Raymond James. Shares up 2% premarket.
CRISPR Therapeutics (NASDAQ:CRSP) downgraded to In Line with a $52 (flat) price target at Evercore ISI. Shares down 3% premarket.
Eyenovia (NASDAQ:EYEN) downgraded to Market Perform at Oppenheimer. Shares down 3% premarket.
ResMed (NYSE:RMD) downgraded to Neutral with a $174 (9% upside) price target at UBS.
https://seekingalpha.com/news/3537231-bluebird-up-2-premarket-on-two-new-bullish-calls

EMA accepts Glaxo application for multiple myeloma conjugate

Under accelerated assessment status, the European Medicines Agency (EMA) has accepted for review GlaxoSmithKline’s (NYSE:GSK) marketing application seeking approval to use antibody-drug conjugate belantamab mafodotin to treat patients with relapsed/refractory multiple myeloma whose prior therapy included an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.
Belantamab mafodotin consists of a humanized anti-B cell maturation antigen monoclonal antibody linked to a cytotoxic agent called auristatin F.
https://seekingalpha.com/news/3537269-ema-accepts-glaxo-application-for-antibody-drug-conjugate-for-multiple-myeloma

CorMedix up 11% on accelerated review of Neutrolin in U.S.

Thinly traded micro cap CorMedix (CRMD +10.6%) is up on below-average volume in early trade in reaction to its announcement that the FDA has agreed to a rolling review of its marketing application seeking approval for Neutrolin for the prevention of catheter-related bloodstream infections in hemodialysis patients.
The company continues to expect the FDA nod in H2.
https://seekingalpha.com/news/3537344-cormedix-up-11-on-accelerated-review-of-neutrolin-in-u-s

Corvus Pharma up 4% on updated CPI-818 data

Thinly traded micro cap Corvus Pharmaceuticals (CRVS +3.6%) perks up on below-average volume on the heels of updated data from a Phase 1/1b clinical trial evaluating CPI-818 in patients with T-cell lymphomas. The results were presented at the T-Cell Lymphoma Forum in La Jolla, CA.
No dose-limiting toxicities or serious/life-threatening treatment-related adverse events have been observed in 16 subjects who have received one of four strengths (100 mg – 600 mg) of CPI-818 twice daily.
Median follow-up is now three months. 11 patients remain on therapy. One patient with cutaneous T-cell lymphoma (CTCL) who received the 200 mg dose showed a reduction in lymphadenopathy and improved PET scan while another CTCL patient who received 400 mg showed improved cutaneous disease.
Pharmacokinetics and occupancy studies have been consistent with expectations.
Orally administered CPI-818 is a small molecule T-cell signaling pathway inhibitor. Specifically, it inhibits an enzyme called interleukin-2-inducible T-cell kinase (ITK) and is designed to block malignant T cell growth and modulate immune responses.
https://seekingalpha.com/news/3537354-corvus-pharma-up-4-on-updated-cpiminus-818-data

Inovio’s INO-3106 shows encouraging action in pilot study

Inovio Pharmaceuticals (INO -11.6%) announces encouraging data from a just-published pilot study evaluating immunotherapy INO-3106 in patients with recurrent respiratory papillomatosis, a rare disorder characterized by the development wart-like growths (papillomas) in the respiratory tract.
The results showed that INO-3106 generated an immune response and engagement and expansion of an HPV 6-specific cellular response, including cytotoxic T cells. Two participants who previously required ~two surgeries each year to manage their disease were able to delay the need for surgery to a “robust degree.” One was surgery-free for 584 days while the other has remained surgery-free for over 915 days.
Shares are down 12% on continued profit-taking from its coronavirus outbreak-stoked runup.
https://seekingalpha.com/news/3537363-inovios-inominus-3106-shows-encouraging-action-in-pilot-study

As China battles coronavirus, should other nations worry about drug supply?

Worries about pharma’s reliance on China for its supply of key drug ingredients have popped up in the U.S. from time to time before. Now, the rising coronavirus has sparked the fear again.
As of Sunday, China had reported more than 17,205 confirmed cases of 2019-nCoV in humans. The death toll has reached 361. The mushrooming case count and various measures aimed at thwarting the disease are straining medical supplies in China, though it’s mostly protection products, such as masks, running short so far.
But as the virus continues to spread across China and beyond, one question emerges: If China prioritizes drugs for its own use amid surging domestic demand—or if the outbreak spurs further bans on international travel and trade, such as the restrictions now imposed by the U.S.—can other parts of the world sustain an adequate drug supply?
There’s no question that China is a major supplier of drug ingredients to the U.S., especially for widely used generics. For example, according to U.S. International Trade Commission data cited in a U.S.-China Economic and Security Review Commission report (PDF), China accounted for a 70.4% share of U.S. antibiotic imports in 2013. Today, that number may be even higher at a dominant 97%, according to Gary Cohn, previously chief economic adviser to President Donald Trump, as quoted by Yanzhong Huang, a senior fellow for global health at nonprofit think tank the Council on Foreign Relations (CFR).
And questions about that dependence on Chinese sources for essential medicines have repeatedly surfaced in the U.S.—once as tainted valsartan was first traced to an API from China’s Zhejiang Huahai Pharmaceutical, once amid U.S.-China trade tension and once as an African swine fever threatened heparin supply. And that’s just in the last few years.
For instance, in the heat of the now partly resolved U.S.-China trade war, Li Daokui, an economist at Tsinghua University and an adviser to Beijing, raised the possibility of China curbing exports of antibiotics as a countermeasure.
“Just as some international analysts have pointed out, we are indeed at the mercy of others when it comes to computer chips, but we are the world’s largest exporter of vitamin and antibiotic ingredients,” Li said last March during a speech at a national advisory conference, as quoted by state-run Xinhua (Chinese). “If we cut back exports, some western countries’ medical system won’t operate well.”

China at least isn’t likely to throw the first punch. As CFR’s Huang noted in his blog post, China needs innovative finished drugs made in western countries for diseases such as cancer. However, the coronavirus epidemic adds a different fold of uncertainty: domestic demand.
Supplies of a traditional Chinese herbal concoction called shunaghuanglian immediately ran out both online and in pharmacies after state media reported Friday that the drug could “inhibit” the new deadly coronavirus.
The report cited research at the Chinese Academy of Science’s Shanghai Institute of Materia Medica and the Wuhan Institute of Virology. Even though the idea was quickly rejected by the wider science community, it does show China—with a population of 1.4 billion—can deplete drug supplies amid an epidemic. By that time, it simply might not have enough left for the rest of the world.
“I would be asking my supply chain folks, what do we have coming from China, what’s our inventory, and if we don’t have enough, can we get as much as fast possible?” Steven Lynn, an FDA official turned consultant, said in a Stat report. “And remember, this isn’t just a U.S. problem. It’s a global problem if China starts shutting down its borders.”

Multinational pharma companies say they are well prepared, though.
“Pfizer consistently and diligently monitors the supply of our medicines,” a Pfizer spokesman told FiercePharma in a statement Friday. He pointed to the company’s 40 self-owned sites and more than 200 suppliers globally, “which provide capacity and redundancy as needed.” Most of its finished products and APIs come from countries other than China, he said.
Johnson & Johnson is also on the lookout for the coronavirus situation. “We have robust business continuity plans in place to prepare for unforeseen events and to meet the needs of the patients, customers and consumers who depend on our products,” a J&J spokesperson said.
That includes “critical inventory” at major distribution centers outside high-risk areas, the spokesperson said, as well as working with external suppliers.
A Roche representative told FiercePharma the Swiss drugmaker has one API for global demand coming from China “with existing stock reserves and the opportunity to source from another location,” adding that the company has “robust plans for dealing with the impact of potential health crises.”
https://www.fiercepharma.com/pharma-asia/as-china-battles-coronavirus-should-other-countries-worry-about-their-drug-supply

BOQI International to Acquire China Medical Distributor

BOQI International Medical Inc. (BIMI) (“BIMI” or the “Company”) today announced that it has entered into a stock purchase agreement (the “Agreement”) to acquire Chongqing Guanzan Technology Co., Ltd., (“Chongqing Guanzan”) through its wholly-owned subsidiary Beijing Xin Rong Xin Industrial Development Co., Ltd. (“Buyer”)
Chongqing Guanzan is a Chinese medical distributor with distribution channels covering over 4,000 pharmacies, over 4,000 clinics, 50 hospitals and 130 pharmaceutical companies nationwide. Chongqing Guanzan also has about ten world-leading medical device suppliers such as Stryker, GE, Siemens, Philips and Olympus.
Pursuant to the Agreement, the Buyer will purchase all the issued and outstanding shares (the “Shares”) of Chongqing Guanzan. The aggregate purchase price for the Shares is RMB 100,000,000 (currently approximately $14,285,714), to be paid in 950,000 shares of common stock of the Company (the “Stock Consideration”) and RMB 800,000,000 in cash (the “Cash Consideration”). The Stock Consideration will be paid at closing and the Cash Consideration, which is subject to post-closing adjustments based on the performance of Chongqing Guanzan in 2020 and 2021, will be paid pursuant to a post-closing payment schedule. The closing of the agreement is expected to be on or about April 20, 2020, subject to necessary regulatory approvals.
“By joining BOQI International Medical, Chongqing Guanzan and our employees will benefit from its supply chain management, as well as the greater resources of a larger, public company,” said Xiaoping Wang, Chief Executive Officer of Chongqing Guanzan. “Importantly, we will maintain our continued commitment to outstanding product quality and strong relationships with suppliers and customers.”
“This is a milestone acquisition which substantially accelerates our pharmacy expansion and member growth in Southwest China,” said Mr. Tiewei Song, Chief Executive Officer and President of BOQI International Medical Inc. “Southwest China has about 200 million people and increasing market demand, which is a key area of our expansion strategy. The acquisition enhances our market position in Southwest China by bringing vital distribution channels, a best-in-industry management team, and local media influence. By consolidating new distribution channels, we can increase distribution channel efficiency and ensure supply during the current coronavirus outbreak. Based on our extensive engagement with Chongqing Guanzan over the past several months, we are confident that Chongqing Guanzan’s support will enable BOQI International Medical to execute on its strategy and next phase of growth.”
https://finance.yahoo.com/news/boqi-international-medical-enters-material-142335046.html