Saturday, September 29, 2018
Apellis Pharmaceuticals (APLS) PT Raised to $34 at Citi
https://www.streetinsider.com/Analyst+Comments/Apellis+Pharmaceuticals+%28AP
Antares ATRS PDUFA set for September 29
Antares Pharma, Inc. (NASDAQ: ATRS) announced that the FDA has accepted its resubmitted New Drug Application (NDA) for the Complete Response Letter (CRL) of XYOSTED (testosterone enanthate subcutaneous injection). The FDA considered this resubmission a class 2 response and has assigned a PDUFA date of September 29, 2018.
Diabetes Patients Turn To Black Market For Affordable Insulin
After years of rising insulin prices, a growing number of diabetics and their families are now facing some tough choices when it comes to paying for the drug.
Some are turning to the black market to buy illegal insulin.
“So many people are dying because they just can’t afford their insulin,” parent Doreen Rudolph said.
Rudolph says she’s doing everything she can to make sure that doesn’t happen to her 27-year-old daughter, Nicole, a Type-1 diabetic.
When her daughter was first diagnosed, Rudolph says a vile of insulin cost about $21.
“Then it went up to 31, 45, 200, and then $400 a vile,” the desperate parent explained.
Even with insurance, Nicole now pays $1,300 every three months out of pocket.
“You pay or you die,” Rudolph conceded.
A recent study from Yale found one in four patients are now putting themselves at risk by rationing their insulin to help off-set the cost.
CBS2 found others are turning to a growing black market where they buy the drug at a fraction of the price.
“$200 for two boxes,” CBS2’s John Dias said, while speaking with a black market insulin seller.
Dias easily found insulin for sale online. They were posted by people like one woman from New Jersey, who told him as a diabetic herself, she has extra to sell.
“On one level, it’s understandable that people would look for other ways to find less expensive insulin,” Dr. Robert Gabbay with the Joslin Diabetes Center said.
He added that the practice is not only illegal, it could have fatal consequences.
“Who knows if it’s insulin but even if you know it’s insulin the safety margin and dosage of insulin is pretty narrow.”
“It’s ridiculous that it’s becoming a black market item,” Rudolph added. “In other countries, you can get insulin for $11 and it’s the same companies that are selling it.”
In an interview with CBS News last year, a spokesperson for the trade group that represents U.S. pharmaceutical manufacturers said the problem is not with the rising cost of the drug so much as with patients’ increasing insurance deductibles.
“It’s very upsetting that our government is allowing this… Somebody should care about us, the citizens,” a tearful Rudolph said.
The Justice Department is now investigating these price hikes. The American Diabetes Association is also calling for Congress to hold hearings on affordable insulin access.
Friday, September 28, 2018
Softbank-backed cancer diagnostics firm Guardant Health set for $200M IPO
Guardant Health, which makes non-invasive blood-based cancer diagnostics tests, announced terms for its IPO last Friday.
The Redwood City, CA-based company plans to raise $200 million by offering 12.5 million shares at a price range of $15 to $17. At the midpoint of the proposed range, Guardant Health would command a fully diluted market value of $1.4 billion and an enterprise value of $944 million.
Guardant Health was founded in 2013 and booked $67 million in sales for the 12 months ended June 30, 2018. It plans to list on the Nasdaq under the symbol GH. J.P. Morgan and BofA Merrill Lynch are the joint bookrunners on the deal. It is expected to price during the week of October 1, 2018.
ObsEva Phase 2b trial shows sustained efficacy, safety, for endometriosis pain
– Linzagolix overall efficacy and safety maintained or improved at week 24
– Linzagolix 75mg once daily showed no clinically significant impact on Bone Mineral Density (BMD), supporting further development with no need for add back therapy (ABT)
– Linzagolix 200mg once daily results support further development with low dose add back therapy (ABT)
– Initiation of Phase 3 endometriosis trials expected in early 2019
ObsEva SA , a Swiss clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for serious conditions that compromise a woman’s reproductive health and pregnancy, today announced additional positive results from the EDELWEISS clinical trial of its oral GnRH receptor antagonist, linzagolix, for the treatment of endometriosis-associated pain.
In the EDELWEISS trial, hallmark pain symptoms of endometriosis, dysmenorrhea (DYS) and non-menstrual pelvic pain (NMPP), showed sustained reduction or further improvement after 24 weeks of treatment, as compared to the positive 12-week results that were announced in June 2018. Sustained efficacy was also seen in additional endpoints such as dyspareunia and dyschezia, as well as in the assessments of patient well-being, most notably the Patient Global Impression of Change (PGIC) and Endometriosis Health Profile-30 (EHP-30) questionnaire.
The main pain efficacy endpoints of the EDELWEISS clinical trial were reported as a responder analysis, with responses defined as a reduction of at least 30% in pain, recorded daily via electronic diary using a verbal rating scale (VRS) of 0 (no pain) through 3 (severe pain).
“We are very pleased with these favorable results that further demonstrate the differentiated therapeutic potential of linzagolix for alleviating the severe, painful and chronic symptoms of endometriosis. These data strongly validate ObsEva’s development strategy for linzagolix as a potential best in class oral GnRH antagonist,” said Dr. Loumaye, co-founder and Chief Executive Officer of ObsEva.
Roche jumps on Tregs trend with a potential $750M deal
- Roche will pay more than $80 million upfront to snag a preclinical candidate focused on regulatory T cells, a trending research area in immuno-oncology that the Swiss pharmaceutical giant hopes will complement its blockbuster drug Tecentriq in treating cancer.
- Tusk Therapeutics announced Friday it had inked the takeover deal on Sept. 27, handing over its experimental antibody to Roche for 70 million euros with potential milestone payments worth up to an additional 585 million euros ($677 million). The private Stevenage, U.K.-based firm will spinout into a new, independent company called Black Belt Therapeutics to develop its other preclinical asset.
- Roche called its newly acquired candidate “the most advanced asset” to test whether an antibody can deplete harmful regulatory T cells that normally suppress immune reactions against cancer cells, as a company spokesperson described in an email to BioPharma Dive.
Tusk had two preclinical regulatory T cell, or Tregs, treatments in development, respectively targeting two specific proteins: CD25 and CD38. Roche will take CD25 in this deal, while Tusk spins out into Black Belt with CD38.
Tusk stated it expects clinical trials with cancer patients to start by the end of 2019.
“Tusk’s antibody has been designed to deplete these harmful Tregs, while not interfering with other immune cells acting against the tumor,” a Roche spokesperson stated in an email to BioPharma Dive. “The importance has not been evaluated in humans yet. However, we believe that this is the most advanced asset to test this hypothesis.”
Roche highlighted Tecentriq (atezolizumab) as a potential combination partner, but its spokesperson also noted “other combinations may be evaluated in the future.”
Tusk CEO Luc Dochez highlighted the anti-CD25 antibody earlier this year in an April presentation at the American Association for Cancer Research.
“Unlike existing CD25 antibodies, our antibody has the ability to deplete Tregs without inhibiting effector cell responses,” he said at the time. “Based on the promising pre-clinical data, we believe that our anti-CD25 candidates will be an ideal combination partner for existing standard of care and immuno-oncology treatments.”
Roche is far from the first pharma to buy into the space, as it’s been a trendy area in immuno-oncology over the past year. Celgene, Novartis and Eli Lilly all reached licensing deals in 2017 for various Tregs-related assets.
In July 2018, the gene therapy biotech Sangamo bought TxCell for $84 million in a deal expected to close by the end of this year.
Tusk was founded in 2014 and based at the Stevenage Bioscience Catalyst in the U.K, a geographic biotech hotspot that also features the Cell and Gene Therapy Catapult, an accelerator that gained several new manufacturing licenses earlier this month.
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