Tuesday, October 2, 2018
William Blair says market ‘significantly’ undervaluing Portola’s Andexxa
William Blair analyst Matt Phipps says a call he hosted yesterday with Jean Marie Connors, M.D., associate professor of medicine and medical director of the hemostatic and antithrombotic stewardship program and anticoagulation management service at Brigham and Women’s Hospital, to discuss the use of reversal agents in patients who experience major bleeding events on anticoagulants such as factor Xa inhibitors, highlighted the “significant opportunity” for Portola Pharmaceuticals’ Andexxa. The call put a spotlight on the “sizable market opportunity” for Andexxa once the commercial supply amendment is approved, Phipps tells investors in a research note. The analyst continues to believe Andexxa has blockbuster potential based on the “significant and growing market opportunity” for the reversal of factor Xa inhibitors. Further, he sees an opportunity for increased utilization following approval in patients requiring emergency surgery, potentially increasing the average patients per month treated with Andexxa. The analyst believes the market continues to “significantly undervalue” the potential of Andexxa, as well as near-term catalysts for Portola, including expanding commercialization across the United States and regulatory approval in Europe. He keeps an Outperform rating on the shares.
https://thefly.com/landingPageNews.php?id=2798659
Inovio gains after positive data published
Shares of Inovio (INO) are spiking higher after the company announced the publication of results in a major cancer journal, from a study of MEDI0457. TREATED WITH MEDI0457: According to an earlier statement from Inovio, a paper published in a major cancer journal detailed results of a patient with head and neck cancer treated with MEDI0457 achieved a sustained complete response on treatment with a subsequent PD-1 checkpoint inhibitor. In the Inovio-sponsored study of 22 patients with head and neck squamous cell carcinoma, the company reported 91% showed T cell activity in the blood or tissue. MEDI0457 — formerly called INO-3112 — was in 2015 licensed to MedImmune, the global biologics research and development arm of AstraZeneca (AZN). These immune data, as well as the financial terms of the license agreement, have been previously reported by Inovio. STUDY SUPPORTS HPV AND ONCOLOGY PROGRAMS: Inovio CEO Dr. J. Joseph Kim said, “We are buoyed by the study as it lends support to all of our HPV and oncology programs. These data demonstrated that Inovio’s technology based in MEDI0457 can generate durable HPV16/18 antigen-specific peripheral and tumor immune responses. The study supports our belief that this approach may be used as a complementary strategy to PD-1/PD-L1 inhibition in HPV-associated head and neck and other types of cancer to improve therapeutic outcomes. Inovio is collaborating with MedImmune as well as Genentech (RHHBY) and Regeneron (REGN) in efficacy trials coupling Inovio’s DNA-based cancer immunotherapies with checkpoint inhibitors designed to increase response rates with data expected in 2019.” ANALYST RAISES PRICE TARGET: Stifel analyst Stephen Willey resumed coverage of Inovio with a Buy rating and $8 price target, citing his favorable view of the clinical risk underlying the ongoing Phase 3 VGX-3100 development program in patients with HPV+ cervical HSIL. He sees the company’s earlier-stage immuno-oncology development efforts and externally-funded infectious diseases programs as additional sources of longer-term upside. PRICE ACTION: Shares of Inovio Pharmaceuticals are up over 16% to $6.22 per share in afternoon trading.
Rexahn presents prelim Phase 2a data on pancreatic cancer med
Rexahn Pharmaceuticals announced earlier that preliminary safety and efficacy data from the ongoing Phase 2a clinical trial of RX-3117 in combination with Abraxane in patients newly diagnosed with metastatic pancreatic cancer were being presented in a poster presentation at the fifth NCI Pancreatic Cancer Symposium held October 2-3, 2018 at the National Institutes of Health. “These preliminary data are encouraging, showing that the combined administration of RX-3117 and Abraxane in newly diagnosed metastatic pancreatic cancer patients appears to be safe and well tolerated and showing evidence of clinical activity. As of September 19, 2018, there was one complete response and three partial responses from the first 14 evaluable patients. In addition, there were eight patients with stable disease who had tumor reductions of up to 16% and who are still being actively dosed. We are encouraged by this preliminary data reflecting a disease control rate of 86% and an overall response rate of 29%. We look forward to completing the study enrollment and plan to report the final data in 2019,” said Dr. Ely Benaim, M.D., chief medical officer of Rexahn. “The safety profile of RX-3117 continues to be encouraging as it can be administered at its recommended Phase 2 dose together with the maximal labeled dose of Abraxane without producing an increase in severe adverse events. This differs from current standard of care where the doses of both gemcitabine and Abraxane, when given in combination, may have to be reduced to avoid grade 3 and 4 dose limiting toxicities,” added CEO Peter Suzdak.
https://thefly.com/landingPageNews.php?id=2798615
Pyxus Canada unit gets cannabis cultivation license from Health Canada
Pyxus International Inc. (NYSE: PYX) is pleased to announce that its indirect Canadian subsidiary, Goldleaf Pharm Inc., has received its Access to Cannabis for Medical Purposes Regulations (ACMPR) cultivation license from Health Canada. The license, awarded September 28, 2018, permits Goldleaf Pharm to begin cultivating medicinal cannabis at its Simcoe, Ontario facility.
“This is an important step, and an exciting time, for us at Goldleaf Pharm,” said Larry Huszczo, Goldleaf Pharm’s co-founder. “We have a state of the art 20,000 square foot indoor growing facility, and recently acquired 20-acres of adjacent property, giving us the ability to expand to more than 700,000 square feet of production space to cultivate cannabis. I am very proud of our team, which has worked diligently to meet Health Canada’s requirements.”
Goldleaf Pharm is a subsidiary of Pyxus’ indirect Canadian subsidiary, FIGR Inc. This latest milestone follows shortly after an announcement by FIGR that its Charlottetown subsidiary, Canada’s Island Garden Inc. (CIG), received approval from Health Canada for the sale of medicinal cannabis oils. CIG previously announced a supply agreement with the province of Prince Edward Island for 1,000 kilograms/kilogram equivalent of cannabis products.
With this development, FIGR’s two subsidiaries are now both licensed to produce medicinal cannabis in Canada. This also places FIGR’s subsidiaries in a position to produce cannabis for adult recreational use in Canada after October 17, 2018, when it is set to become legal in that country.
Clovis Gets Breakthrough Therapy Tag for Prostate Cancer Med
Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Rubraca® (rucaparib) as a monotherapy treatment of adult patients with BRCA1/2-mutated mCRPC who have received at least one prior androgen receptor (AR)-directed therapy and taxane-based chemotherapy.
Breakthrough Therapy designation is granted by the FDA to investigational agents intended to treat a serious or life-threatening disease or condition and whose preliminary clinical evidence may demonstrate substantial improvement on at least one clinically significant endpoint over available therapy. The FDA previously granted Breakthrough Therapy designation to Rubraca for the monotherapy treatment of certain advanced ovarian cancer patients and then in December 2016 approved Rubraca for the treatment of certain adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies. The FDA subsequently approved Rubraca in a second indication, the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy, in April 2018.
“We are committed to the rapid development of Rubraca in mCRPC and we are obviously pleased to receive Breakthrough Therapy designation. We look forward to presenting the data that served as the basis of our BTD application at the ESMO conference later this month,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “We hope the decision by the FDA to grant this Breakthrough Therapy designation for Rubraca offers encouragement to the prostate cancer community, and we will do our best to make Rubraca available to eligible prostate cancer patients as quickly as possible.”
This most recent Breakthrough Therapy designation was granted to Rubraca based on initial efficacy and safety results from TRITON2, the Phase 2 study of Rubraca in men with advanced prostate cancer with BRCA 1/2 mutations (germline or somatic) and deleterious mutations of other homologous recombination (HR) repair genes, in the metastatic castration-resistant setting.
Initial data from the TRITON2 clinical study, which served as the basis for BTD, will be presented for the first time at the 2018 European Society for Medical Oncology (ESMO) Congress taking place October 19-23, 2018, in Munich, Germany.
“We are pleased the FDA has granted Breakthrough Therapy designation to Rubraca in mCRPC,” said Howard R. Soule, Ph.D., Executive Vice President and Chief Scientific Officer of the Prostate Cancer Foundation. “There is tremendous need for new therapeutic options in advanced prostate cancer. In particular, we are enthusiastic about the potential for targeted therapies that may provide more meaningful benefit to patients with specific genetic mutations.”
Data from the TRITON2 clinical study will also be presented in an oral presentation at the 25thAnnual Prostate Cancer Foundation Scientific Retreat, taking place October 26-28, 2018, in Carlsbad, CA.
Reduce Snoring by Playing a Smartphone App
In partnership with the University of Minnesota’s Sleep Centers and the Medical Devices Center, researchers recently demonstrated the ability to reduce snoring through a noninvasive therapy facilitated by a smartphone game.
Snoring occurs when the upper airway muscles relax, obstructing a patient’s airflow, which causes noisy tissue vibrations during inhalation. In their research paper, “Smartphone-based delivery of oropharyngeal exercises for treatment of snoring,” Brian Krohn, PhD., Adam Black, PhD., and Dr. Umesh Goswami, MD, prove that these noisy vibrations can be reduced by performing an oral therapy designed to strengthen and tone specific muscles within the upper airway.
Snoring continues to be the most common complaint in sleep medicine clinics, affecting 35 percent of all adults. In addition to negatively impacting sleep partners, snoring may be a predictor of obstructive sleep apnea, which can lead to high blood pressure, inflammation, and numerous other health risks.
Existing snoring treatments are often uncomfortable and require expensive devices that need to be worn during sleep. They tend only to address the symptoms of snoring, not the root cause.
Recognizing the universal need for a simpler solution to snoring, Dr. Krohn enlisted the help of sleep physicians, speech pathologists, and video game developers to create Soundly, the first app-based therapy clinically proven to reduce snoring. Soundly accomplishes this by presenting a visually stimulating, gamified therapy in which an onscreen character responds to scientifically optimized vocal commands dictated by the user.
“The ‘ee’ sound moves the tongue to the front of the mouth and the ‘aw’ sound moves the tongue to the back of the mouth,” explains Dr. Krohn, Soundly’s founder and CEO. “Meanwhile, the ‘ng’ sound engages the muscles of the soft palate. By saying ‘nee’ and ‘naw’ in succession, the user is able to move their in-game character while doing the perfect pushup for their oropharyngeal muscles.”
With 100 percent of test subjects’ bed partners reporting a reduction in snoring and support from the medical sleep community, Soundly continues to focus its app on delivering a science-driven sleep therapy through the vehicle of a gamified smartphone app. The newly updated Soundly app is available in the iOS App Storeand will debut at Somnex, The Sleep Show in London, Oct. 12-14. Get details here.
About Soundly:
Soundly is a Minnesota-based medical technology company founded in 2017. Research for Soundly is supported by the National Institute of Health (NIH) and the National Science Foundation (NSF) in conjunction with a 2017 sleep study. Research partners include the Medical Sleep Clinic, Fairview Sleep Centers, and Medical Devices Center.
Soundly is a Minnesota-based medical technology company founded in 2017. Research for Soundly is supported by the National Institute of Health (NIH) and the National Science Foundation (NSF) in conjunction with a 2017 sleep study. Research partners include the Medical Sleep Clinic, Fairview Sleep Centers, and Medical Devices Center.
To download a free trial of Soundly, visit the app store from any iPhone or iOS device.
For more information on Soundly, visit www.sleepsound.ly or contactcoreybrenner@soundlyapp.com
FDA OKs Paratek-Allergan Acne Treatment
Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a biopharmaceutical company focused on the development and commercialization of therapies based upon tetracycline chemistry, today announced that the U.S. Food and Drug Administration (FDA) has approved SEYSARA™ (sarecycline) for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. Paratek has exclusively licensed U.S. development and commercialization rights of SEYSARA for the treatment of acne to Allergan PLC, who has assigned such rights to Almirall SA. Paratek retains development and commercialization rights in the rest of the world. SEYSARA (sarecycline) is a once-daily, oral, narrow spectrum tetracycline-derived antibiotic with anti-inflammatory properties for the potential treatment of moderate to severe acne in the community setting. Under the parties’ agreement, Paratek earned a $12 million milestone payment upon FDA approval and is now entitled to receive tiered royalties at rates ranging from high-single to low double digits on net sales of SEYSARA.
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