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Wednesday, June 19, 2019

Jounce Starts Phase 2 for Lung, Urothelial Cancer Combo Study

Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, today announced that it has initiated dosing in the Phase 2 EMERGE clinical trial of its lead product candidate, vopratelimab, in combination with ipilimumab in patients with non-small cell lung cancer (NSCLC) or urothelial cancer who have progressed on or after PD-1/PD-L1 inhibitor therapies. These patient populations represent a rapidly growing area of unmet need as PD-1 inhibitors move into earlier lines of therapy, with few options and no established standard of care for patients who progress after a PD-1/PD-L1 inhibitor.
The Phase 2 EMERGE clinical trial of vopratelimab and ipilimumab builds upon the original science from our founders as well as the reverse translational subset analysis from patients who benefitted in our ICONIC trial versus those who did not. Vopratelimab treatment resulted in the emergence of ICOS hi CD4 T effector cells in the peripheral blood and emergence of these cells was associated with response and improvements in progression free survival and overall survival, as presented at the 2019 American Association for Cancer Research Annual Meeting, said Beth Trehu, M.D., chief medical officer of Jounce Therapeutics. Ipilimumab is known to induce a population of ICOS hi CD4 T cells, making it a scientifically logical combination partner for vopratelimab in the EMERGE study, as we have shown vopratelimab stimulates, expands and sustains ICOS hi CD4 T cells. We are pleased to have begun enrollment in the EMERGE clinical trial and expect to report preliminary efficacy data in 2020.
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Oklahoma medical examiner testifies in state opioid lawsuit vs. J&J

Oklahoma’s medical examiner has provided tragic details of opioid-related deaths during testimony in the state’s lawsuit that alleges drug manufacturer Johnson & Johnson contributed to the opioid epidemic.
Among the cases outlined Tuesday by Dr. Eric Pfeifer was that of a 28-year-old mother with a history of back pain who had just been placed on fentanyl patches and was found dead on her daughter’s birthday.
Pfeifer also read investigative narratives involving the death of a 53-year-old woman found dead sitting up at her dining room table and of a 55-year-old woman found by her husband in a bathtub overflowing with water.
The lawsuit alleges drugmakers marketed highly addictive opioids in a way that overstated their effectiveness and underplayed the risk of addiction. Johnson & Johnsonhas denied wrongdoing.
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Teva Launches Generic of Tracleer® (bosentan) BP Tablets in US

Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced the launch of a generic version of Tracleer®1 (bosentan) tablets, 62.5 mg and 125 mg, in the U.S.
Bosentan Tablets are an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group 1) in adults to improve exercise ability and to decrease worsening of the condition. PAH is high blood pressure in the blood vessels of the lungs. Due to the risks of liver damage, and serious birth defects, Bosentan Tablets are available only through a restricted distribution program called the Bosentan REMS Program.
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Philips gets FDA premarket OK on HeartStart OnSite, Home defibrillators

Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced that the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has approved the company’s premarket approval (PMA) application for its HeartStart OnSite defibrillator [1] and HeartStart Home defibrillator [2], and the relevant supporting accessories, such as batteries and pad electrodes.
Philips’ HeartStart OnSite and HeartStart Home defibrillators are the only over-the-counter automated external defibrillators (AEDs) available to consumers in the US, while the HeartStart Home defibrillator is the only AED specifically indicated for home environments.
“We are committed to delivering high quality, innovative AEDs to provide personalized therapy to victims of sudden cardiac arrest,” said Arman Voskerchyan, Business Leader Therapeutic Care at Philips. “Premarket approval for our HeartStart OnSite and HeartStart Home defibrillators, currently the only over-the-counter AEDs available in the US, reflects the robust work of our teams that delivered the strong and extensive technical, clinical and production data included in the PMA filing for these devices.”
PMA for Philips’ HeartStart OnSite and HeartStart Home defibrillators can be found here. These devices already had FDA 510(k) clearance, but are now subject to PMA.
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Glaxo kicks off sale of $1.2 billion consumer health assets

GlaxoSmithKline (GSK) has kicked off the sale of some consumer health brands as it seeks to raise about £1 billion before pressing ahead with a spinoff of its consumer healthcare business, sources told Reuters.

The drugmaker has bundled the non-core drugs into three different portfolios and has hired boutique investment bank Greenhill to market the products to separate bidders, said three sources familiar with the matter, speaking on condition of anonymity.
Information packages for two portfolios consisting of Latin American drugs and Physiogel skin care products were sent out to prospective bidders earlier this week, the sources said.
The sale of a third portfolio of European drugs will kick off after the summer, with a much higher price tag attached due to strong interest from private equity investors, they said.

GSK is streamlining its product offering as it prepares to fold its consumer business into a joint venture with Pfizer in the second half of this year, creating a market leader that will primarily look to the United States and China for growth.
The FTSE 100 drugs maker said that within three years of closing the Pfizer deal it wanted to demerge and float the consumer health business.
If successful, GSK will split into two distinct businesses: one focused on consumer, the other on pharmaceuticals and vaccines.
GSK, whose consumer brands include Sensodyne, has secured a controlling stake in the Pfizer partnership of 68%, with the U.S. drug giant holding the balance.
When the Pfizer joint venture was unveiled, GSK said it was targeting net divestment proceeds of about £1 billion over the 2019-2020 period.
One of the sources said the three portfolios which are up for sale have combined revenues of £200 million-£300 million pounds, with the European portfolio representing about 40 percent of the combined sales.
Private equity funds including Advent – which bought generic drug firm Zentiva last year – are expected to bid for the European assets, the sources said.
Other prospective bidders may include CVC Capital Partners, which backs Italian drug firm Recordati, the sources said, along with a consortium of Bain Capital and Cinven, which control Germany’s Stada, the owner of UK consumer products maker Thornton & Ross.
On June 7 Stada said it would buy a smaller portfolio of six, mainly Britain-focused brands from GSK to bolster its presence in Europe.
Another source said the Latin American portfolio, which has a strong presence in countries like Mexico and Argentina with revenues of about £90 million, is expected to be sold to local industry players.
The Physiogel portfolio may draw interest from Asian companies as it consists of GSK’s branded skincare products which have a strong presence across Asia in countries including South Korea, China, Malaysia and Thailand.
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Biolase adds a bull; shares gain

Benchmark starts coverage of Biolase (BIOL +9.3%) with a Speculative Buy rating and $2 price target, suggesting about 33% upside.
New management’s “laser focus,” says analyst Bruce Jackson, is beginning to pay dividends.
While the Sell-Side rating for Biolase is totally bullish (3 buy ratings now), the Quant rating on Seeking Alpha is Very Bearish.
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Merck considers CMO, CFO for lead role

Merck (MRK +0.1%) is eyeing internal candidates for the CEO role, including Chief Marketing Officer Michael Nally, Chief Financial Officer Robert Davis, and Chief Commercial Officer Frank Clyburn, according to Bloombergsources.
Current CEO Kenneth Frazier doesn’t have a set exit date after Merck abandoned its mandatory retirement age, which would have pushed Frazier out at the end of this year. But the company plans to discuss the candidates, and some external names, at Thursday’s investor event.
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