Henry Schein announced it has completed the acquisition of North American Rescue, the leading provider of survivability and casualty-care medical products to the defense and public-safety markets. The transaction was announced on January 23. As previously reported, NAR generated record sales for the 12 months ended October 31, 2018, of approximately $184M. As stated when Henry Schein announced its agreement with NAR, Henry Schein expects NAR to be neutral to the company’s 2019 earnings per share and accretive thereafter. Financial terms were not disclosed.
https://thefly.com/landingPageNews.php?id=2873627
Monday, March 4, 2019
MyoKardia (MYOK) Reports Positive Six-Month Safety, Efficacy Data
MyoKardia, Inc. (Nasdaq: MYOK), a clinical-stage biopharmaceutical company pioneering a precision medicine approach for the treatment of serious cardiovascular diseases, today announced positive 12- and 24-week safety, efficacy and biomarker data for its investigational drug, mavacamten, from the company’s PIONEER open-label extension (OLE) study. The PIONEER-OLE study enrolled a total of thirteen patients who previously completed the Phase 2 PIONEER-HCM trial. These data reflect the longest duration of mavacamten treatment reported to date.
Mavacamten is being developed for the treatment of symptomatic, obstructive hypertrophic cardiomyopathy (oHCM), in an ongoing Phase 3 pivotal trial, known as EXPLORER-HCM. Patients with oHCM are at an increased risk of heart failure, atrial fibrillation, stroke and death, including sudden cardiac death. There are an estimated 410,000 people with oHCM in the United States, with approximately 65,000 currently diagnosed and seeking medical attention. The EXPLORER-HCM trial is enrolling 220 patients with oHCM. Patients will be randomized 1:1 to receive mavacamten or placebo for 30 weeks with a primary endpoint of clinical response. EXPLORER-HCM topline data is expected in the second half of 2020, with the completion of enrollment expected in the second half of this year.
Biogen to buy Nightstar Therapeutics for about $800M
Biogen Inc said on Monday it will buy Nightstar Therapeutics Plc for about $800 million in cash.
Biogen’s offer of $25.50 per share, represents a premium of 68 percent to Nightstar’s Friday close of $15.16.
5 Biotechs Awaiting Phase 3 Trial Data In March
Clinical trials are major catalysts for biotech/pharma companies as positive study data can boost the stock price while unfavorable results can send the stocks plummeting.
The success rate of phase I clinical programs is the highest, say 63%, while it is the lowest for phase II trials – i.e. 30%. The phase III trials, which are the longest and most expensive trials to conduct, are said to have a success rate of 58%, according to a report from the Biotechnology Innovation Organization on “Clinical Development Success Rates” over the past decade (2006-2015).
Listed below are some of the companies that are expected to report their phase III clinical trial results *this month (if the companies stick to their timeline).
1. Alnylam Pharmaceuticals Inc. (ALNY)
Alnylam Pharma is a commercial-stage RNA interference (RNAi) company. RNAi therapeutics represent a powerful, clinically validated approach for the treatment of people afflicted with rare genetic, cardio-metabolic, hepatic infectious, and central nervous system (CNS)/ocular diseases.
Watch out for…
Top-line results from a phase III study of Givosiran, an investigational RNAi therapeutic, for the treatment of acute Hepatic Porphyrias, dubbed ENVISION, are expected in March 2019.
Hepatic porphyria refers to an abnormal increase of pigments called Porphyrins in the body. It is a rare genetic disease characterized by episodic and potentially life-threatening acute neurologic attacks, which occur most commonly in women in child-bearing years. (Source: Rare Disease Report).
ALNY has traded in a range of $60.27 to $153.99 in the last 1 year. The stock closed Friday’s trading at $85.37, up 0.44%.
2. Ascendis Pharma A/S (ASND)
Ascendis Pharma is a clinical-stage biopharmaceutical company applying its innovative TransCon technology to develop therapeutics that address significant unmet needs.
Watch out for…
Top-line results from a phase III trial comparing once-weekly TransCon hGH with a daily growth hormone therapy in treatment-naïve pediatric subjects with growth hormone deficiency, dubbed heiGHt Trial, are due this quarter.
If the Company sticks to its deadline, the phase III heiGHt Trial data will be reported this month.
We had alerted our premium subscribers to ASND in March 2015 when it was trading around $17.80. In the last 1 year, the stock has traded in a range of $53.21 to $76.99. It closed Friday’s trading at $69.31, down 4.82%.
3. Galapagos NV (GLPG)
Galapagos is a clinical-stage biotechnology company developing medicines for cystic fibrosis, inflammation, and other indications.
The Company’s lead drug candidate is Filgotinib, a highly selective JAK1 inhibitor. Filgotinib is being evaluated in phase III programs in rheumatoid arthritis, Crohn’s disease and ulcerative colitis, and in phase II studies in small bowel Crohn’s disease, fistulizing Crohn’s disease, Sjögren’s syndrome, ankylosing spondylitis, psoriatic arthritis, cutaneous lupus erythematosus, lupus membranous nephropathy, and uveitis.
Watch out for.
Top-line results from phase III trials of Filgotinib in rheumatoid arthritis, dubbed FINCH 1 and FINCH 3, are expected this month.
We had alerted our readers to GLPG in July 2015 when it was trading around $55.30. The stock has traded in a range of $85.00 to $122.28 in the last 1 year. It closed Friday’s trading at $102.30, up 4.79%.
4. Proteon Therapeutics Inc. (PRTO)
Proteon is a late-stage biopharmaceutical company developing therapies to address some of the most urgent needs of hemodialysis and peripheral artery disease patients.
The Company’s lead drug candidate is Vonapanitase, which is under phase III study in patients with chronic kidney disease undergoing surgical creation of a radiocephalic arteriovenous fistula for hemodialysis, dubbed PATENCY 1 AND PATENCY-2.
The PATENCY 1 results were announced in December 2016. Although the trial did not meet its primary endpoint of improved primary unassisted patency, compared to placebo, it showed a 34% reduction in the risk of secondary patency loss over one year, compared to placebo, and a 45% relative increase in fistula use for hemodialysis, compared to placebo. Secondary patency refers to time to fistula abandonment.
Watch out for…
Top-line data from the PATENCY-2 clinical trial are expected in March 2019.
Improvement in fistula use for hemodialysis and secondary patency are the co-primary endpoints in the PATENCY-2 clinical trial.
PRTO has traded in a range of $1.50 to $3.10 in the last 1 year. The stock closed Friday’s trading at $2.71, down 6.87%.
5. Urovant Sciences Ltd. (UROV)
Urovant is a clinical-stage biopharmaceutical company developing innovative therapies for urologic conditions.
The Company’s lead drug candidate is Vibegron, which is under a phase III trial in adults with symptoms of overactive bladder, dubbed EMPOWUR, and a phase II study in women with irritable bowel syndrome (IBS)-associated abdominal pain.
Watch out for…
Top-line data from the EMPOWUR trial are expected by the end of March 2019.
UROV has thus far hit a low of $4.06 and a high of $14.32. The stock went public on the NASDAQ on September 27, 2018, offering its shares at a price of $14 each.
Sunday, March 3, 2019
Novartis positive Phase 3 Cosentyx data for first time in China
- Phase III study shows close to 9/10 patients who received Cosentyx® 300mg achieved clear or almost clear skin during the first 16 weeks of treatment (87%), with rapid onset of relief seen as early as week 3[1]
- Results strengthen unique position of Cosentyx as a rapid and long-lasting complete treatment of psoriatic disease, with over 200,000 patients treated worldwide[2]
- Data is being presented at the 2019 American Academy of Dermatology (AAD) Annual Meeting in Washington, D.C.
Novartis announced today new data in 441 Chinese patients with moderate to severe plaque psoriasis from a Phase III study investigating the efficacy and safety of Cosentyx (secukinumab). The data, part of a broader ongoing 52 week Phase III study in 543 patients, show 97.7% of patients treated with Cosentyx 300mg achieved PASI 75 and 80.9% achieved PASI 90 by week 12, with 87% of patients reaching PASI 90 by week 16. In patients treated with Cosentyx 150mg, 87.8% achieved PASI 75 and 66.4% achieved PASI 90 at week 12[1].
Bay Area Real Estate Issues Hinder Some Startups
San Francisco’s Mission Bay is an exciting area for the biotech industry, with cutting-edge research being conducted by a number of companies. But for years, Mission Bay has been plagued with concerns over a lack of space for startups and other companies
Three years ago, BioSpace put together a report on the lack of space, particularly for startups trying to get some lab space in order to grow the company. While there are a number of incubators aimed at startups in Mission Bay, there just isn’t enough room for everyone. Not only is there little room in the incubators for startups, but there’s also little room in the San Francisco and Bay Area for these companies to find when they need to grow.
Real estate, the price of and lack of, has been an issue in the Bay Area for years. In a recent report from the San Francisco Business Times, the concerns about the lack of space for startups in the Mission Bay area was once again raised as the publication took a look at a number of startups in incubators like QB3 and Bayer CoLaborator. As the Times noted though, there’s just not enough space for those startups. Over the past few years, BioSpace has kept track of real estate concerns in the Bay Area. With a price of about $60 per square foot across the area, many startups cannot afford to tackle such an investment. But, there are new buildings going up across the region with the life sciences in mind. Most recently, there was a report about the expectation that construction will soon begin at Kilroy Oyster Point in South San Francisco.
Kilroy Realty Corporation said it plans to develop, over multiple phases, a state-of-the-art laboratory and office complex that will eventually encompass 11 buildings spread across a nearly 40-acre waterfront site in the Bay Area. The site is fully entitled for 2.5 million square feet. The first phase of development for the site includes three six-story buildings that will total 508,000 square feet on 10 acres.
In addition to the Kilroy project, The Cove, a project of HCP Life Science Estates, broke ground in 2015. The campus design consists of seven buildings ranging in size from 102,000 square feet to 158,000 square feet in both single- and multi-tenant building configurations.
Alexandria Real Estate Equities has also been developing space in the area. Two years ago, the developer cut a deal with Merck to build a nine-story, 294,000 square foot facility with research space and office space. Another development is BioMed Realty’s Gateway of the Pacific project—a proposed 1.3 million square foot campus that will include ample office and laboratory space.
San Francisco has long been known for its high real estate costs, which is why some companies have been looking to the surrounding suburbs to get the best bang for their buck when it comes to real estate. One such area is Pleasanton, Calif. a suburb of San Francisco in Alameda County about 25 miles east of Oakland. Pleasanton and other neighboring communities have been opening space to attract biotech and pharma companies, both startups and established companies.
About 90 minutes south of San Francisco is the town of San Jose. One innovative group based in nearby San Jose saw the need for biotech space and opened the San Jose BioCube. Saam Farahmand, marketing director for San Jose BioCube, told BioSpace that there is now a waiting list for the 37,000 square-foot facility located about an hour from San Francisco. The BioCube offers multiple amenities, such as a reception center, conference center and three research centers – a cell culture room, virus room and a bacteria room. Office space ranges from 100 to 2,000 square feet. Lab space can 500 to 1,300 square feet in size.
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