Rockwell Medical issued a letter to shareholders on behalf of Rob Chioini, President and CEO, which states: “I submitted a response to The 8K that the Company issued this morning May 23, 2018, that I signed, Acc-no: 0001104659-18-035192, is true and accurate and represents correctly what has transpired. We have made appropriate disclosures to the Company’s auditors, and we are following proper governance measures. As CEO, I have instructed the CFO to remain in his duties. As the 8K states, on May 22, 2018, I called an emergency Board meeting for the purpose of discussing a shareholder demand letter requesting an independent investigation and alleging breaches of fiduciary duties and other possible violations of securities and other laws by various directors. The special meeting was called for the sole purpose of discussing various allegations of misconduct by directors and inform the full Board of steps the non-conflicted independent directors have taken to retain counsel and initiate an independent investigation. The call was convened and the directors whose conduct was the subject of the allegations of breaches of fiduciary duties, with securities counsel present, asserted the position that they voted to fire the CEO. As that action was not the purpose of the special meeting, the termination of the CEO, in the opinion of the non-conflicted independent directors, was not effective. The CEO, through counsel, has notified the SEC of the action taken by the directors whose conduct is discussed in the demand letter that gave rise to the investigation. The CEO continues to serve as the CEO consistent with the terms of his employment agreement. The internal investigation is proceeding under direction of the two non-conflicted independent directors Patrick Bagley and Ronald Boyd who have retained qualified and highly experienced counsel to conduct the investigation. The Chairman of Board issued a second conflicting 8K this morning. Therein is referenced a Board meeting in which it is asserted that the CFO, Thomas Klema, was terminated. I have no information to suggest the governance requirements to call such a meeting were followed. The same 8K states that the Board created a Special Transition Committee comprised of Benjamin Wolin, Lisa Colleran, and John Cooper, to provide board-level oversight of the Company’s strategic direction and day-to-day operations during the Company’s transition. I have no information to suggest that the governance requirements for the creation of such a committee were followed. I am informed that the independent investigation has commended. Our expectation is that all directors will cooperate fully with the investigation. I remain committed fully to acting in the best interests of all shareholders.”
Wednesday, May 23, 2018
Myriad: 7 new payer coverage decisions for Prolaris prostate cancer test
Myriad Genetics announced seven new commercial coverage decisions for Prolaris, the company’s market leading prognostic test for patients with prostate cancer.The payers include a top-25 commercial insurer in the United States and in aggregate the payers represent six million new covered lives for Prolaris. These decisions follow the recently updated National Comprehensive Cancer Network NCCN, guidelines that support Prolaris as standard of care in making treatment decisions for patients with low and favorable-intermediate risk prostate cancer.”We are extremely pleased to see accelerating commercial insurer coverage for Prolaris based upon the strong supporting clinical evidence which was underscored by recent NCCN guidelines,” said Nicole Lambert, general manager, Urology. “These decisions will ensure broader patient access to Prolaris allowing for more informed clinical decision making and lower overall healthcare costs to the system.”In aggregate, Prolaris now has insurance coverage for approximately 50% of Prostate cancer patients in the United States. Over 60,000 men have received the Prolaris test to help guide their treatment for prostate cancer.
Epigen, Novo Nordisk in pact to develop kidney disease med
Epigen Biosciences announced that it has entered into a collaboration agreement with Novo Nordisk under which Novo Nordisk has licensed the LPA1 receptor antagonist EPGN696 for development in diabetic and chronic kidney disease and other chronic diseases associated with metabolic syndrome. EPGN696 is an orally available, selective LPA1 receptor antagonist. In preclinical testing, EPGN696 demonstrated efficacy and safety in rodent models of kidney disease by targeting fibrosis, inflammation and growth factor responses. Under the terms of the agreement, Epigen will receive upfront and potential milestone payments upon the achievement of specific development goals up to $200M. In addition, Epigen also will be eligible to receive tiered royalties and milestones on the worldwide sales of products that arise from the collaboration. The two companies will collaborate on the development of EPGN696 for diabetic kidney diseaseand other indications.”Epigen discovered EPGN696 and its LPA1 receptor antagonist portfolio supported by the National Institutes of Health. Entering into a collaboration with Novo Nordisk provides recognition of our core R&D capabilities and the opportunity to make a significant difference for patients living with serious chronic diseases, such as DKD.” Epigen Biosciences, Chief Business Officer, Satheesh B. Ravula said in a statement. “Novo Nordisk is very excited about this opportunity for collaborating with Epigen in diabetic and potentially chronic kidney disease. This is an innovative project strengthening our efforts within this strategically important area for Novo Nordisk. It holds potential to make a significant difference for people with these chronic diseases” said Marcus Schindler, Senior Vice President, Global Drug Discovery in Novo Nordisk
Esperion cholesterol-lowering drug aces a third pivotal trial
In its third pivotal trial readout this year, the 180-mg dose of Esperion’s LDL cholesterol-lowering treatment, bempedoic acid, hit its primary endpoint in a trial of high-risk patients with atherosclerotic cardiovascular disease (ASCVD). And there is more to come—the company expects to report data from two more studies later this year.
The 24-week trial evaluated the treatment in patients with ASCVD or at high risk for ASCVD with hypercholesterolemia whose cholesterol cannot be controlled with background LDL-lowering drugs and who cannot use statins. The study involved about 4,000 patients already on background lipid-modifying meds, with two-thirds of them receiving a daily dose of bempedoic acid and the remainder receiving placebo.
The treatment lowered LDL cholesterol levels by 26%, compared to the 2% decrease achieved by placebo. The treatment group also had a 25% drop in high-sensitivity C-reactive protein (hsCRP), a biomarker of inflammation linked to heart disease, while the placebo group had only a decrease of 3%.
“The dataset from this study is reassuring and highly consistent with what we’ve seen previously with bempedoic acid. For the millions of patients with hypercholesterolemia who are considered statin intolerant and have limited treatment options, bempedoic acid provides meaningful LDL-cholesterol lowering and statin-like reductions in hsCRP,” said Ulrich Laufs, director of the Department of cardiology at Leipzig University and a member of Esperion’s phase 3 executive committee. “The medical community is in need of a new oral therapy which is effective, well tolerated and convenient for this complex patient population who may have run out of other options.”
In March, bempedoic acid put up positive phase 3 results as a monotherapy—it lowered LDL levels 23% from baseline, compared to a 5% increase observed in patients on placebo. The trial involved 269 patients with atherosclerosis, or patients who are at high risk of atherosclerosis whose cholesterol cannot be controlled with lipid-modifying drugs, such as Merck’s Zetia, or the lowest approved starting dose of a statin.
And a few weeks later, the company announced positive data from a phase 2 trial of bempedoic acid as an add-on treatment for patients already taking Repatha, a PCSK9 inhibitor from Amgen, to lower their cholesterol. Topline data showed that patients treated with bempedoic acid had a 27% decrease in LDL levels, while patients who received placebo had a 3% increase in LDL.
Up next? Data from a pair of trials evaluating bempedoic acid alone and in a combination.
“We eagerly anticipate the pivotal Phase 3 study results for our lead product candidate, the bempedoic acid/ezetimibe combination pill, in late August, and the fourth and final pivotal phase 3 study of bempedoic acid, Study 2, in late September. Both studies include ASCVD patients on maximally tolerated statin therapy,” said Esperion CEO Tim Mayleben.
Ex-Gilead R&D Head Emerges as CEO of Startup Kronos Backed by Gilead Chair
Two months after walking away from his role as head of R&D and chief scientific officer at Gilead Sciences, Norbert Bischofberger has re-emerged at the helm of startup Kronos Bio, Inc.
Bischofberger is the president and chief executive officer of the new Cambridge, Mass.-based company that is focused on developing first-in-class therapies that modulate historically recalcitrant cancer targets. The company officially launched this morning with $18 million in seed financing and its new CEO.
Kronos is backed by a number of luminaries in the biotech industry, including Kite Pharmafounder, Arie Belldegrun and as Gilead Sciences’ Chairman John Martin. Other investors in the company include Omega Funds, BellCo Capital and Vida Ventures. Bischofberger also invested some of his own funds into the startup.
Kronos is using technology developed by its scientific founder Angela Koehler of the Koch Institute for Integrative Cancer Research at Massachusetts Institute of Technology. Koehler’s technology uses chemical modulators of transcription factors as part of a small molecule discovery. The company said its approach is “ideally suited for rapid discovery of unique ligands that can be utilized in the generation of novel modulators or degraders of challenging targets such as transcription factors.” Bischofberger, who spent 30 years at Gilead, called the science at Kronos is compelling.
“At its core, it focuses on solutions, not limitations. It is some of the most exciting technology I’ve come across and it opens a new door for applied chemistry to solve some of the greatest challenges we face in the industry today,” Bischofberger said in a statement. “When I started at Gilead, we had approximately 25 employees. I am excited to apply the wisdom and experience I’ve gained and return to my roots in early stage biotechnology.”
Kronos Bio launches with two preclinical programs built upon hits identified from the small molecule microarrays platform, targeting MYC and the Androgen Receptor (AR). The MYC family of transcription factors are master regulators of cell proliferation and differentiation, and MYC expression is dysregulated in a large proportion of human cancers, Kronos said. Kronos is currently pursuing lead compounds that have demonstrated activity in multiple MYC-driven cancer models.
Likewise, the AR is a primary driver of disease progression in prostate cancer. The company is also pursuing “multiple hit series that target AR and its splice variants.”
Martin, the chairman of Gilead, said Kronos’ technology creates an opportunity to challenge older notions that some cancer targets cannot or should not be pursued by researchers. He said Bischofberger is “ideally positioned to shepherd this exciting technology into the next stage of development. Martin added that he is thrilled to work with Bischofberger again.
Belldegrun, who served as CEO of Kite Pharma until Gilead acquired it and its FDA-approved CAR-T program last year, will serve as chairman of the Kronos board of directors. By challenging preconceived notions about targets, Belldegrun said the future of the pharma and biotech industry is for those companies that “dare to be first.”
“Angela’s innovative research combined with Norbert’s expertise and track record of success, provides Kronos the opportunity to discover first-in-class treatments for some of the most elusive targets in oncology,” Belldegrun said.
Merck’s Keytruda Gains Another First-Line Treatment, for Lung Cancer
Merck & Co’s anti-PD-1 therapy Keytruda dazzled in its pivotal Phase III KEYNOTE-407 trial in combination with carboplatin-paclitaxel or nab-paclitaxel as first-line treatment for metastatic squamous non-small cell lung cancer (sNSCLC).
The combination met dual primary endpoints—overall survival (OS) and progression-free survival (PFS), and in an interim analysis by the independent Data Monitoring Committee (DMC), the combo treatment had significantly longer OS and PFS than just chemotherapy. The safety profile was consistent with previous studies in lung cancer.
Merck submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA). The data will also be presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in early June.
“As first-line treatment, Keytruda in combination with traditional chemotherapy has now demonstrated an improved survival benefit, compared to chemotherapy alone, in metastatic lung cancer patients with squamous histology,” said Roger Perlmutter, president of Merck Research Laboratories, in a statement. “We look forward to presenting the overall survival and progression-free survival findings from KEYNOTE-407 at the 2018 ASCO Annual Meeting, and are grateful to the patients and ivnestigators for their important contributions to this pivotal study.”
KEYNOTE-407 is a randomized, double-blind, placebo-controlled, Phase III trial. It is looking at Keytruda in combination with carboplatin-paclitaxel or nab-paclitaxel compared to carboplatin-paclitaxel or nab-paclitaxel alone. It evaluated 560 untreated patients with metastatic squamous NSCLC. Patients had no previous systemic therapy or advanced disease.
Keytruda is involved in more than 750 clinical trials in a variety of cancers and treatment settings. So far it is approved to treat melanoma, lung cancer, head and neck cancer, classical Hodgkin lymphoma, urothelial carcinoma, microsatellite instability-high (MSI-H) cancer, and gastric cancer.
Earlier data from the trial involving 204 patients had an overall response rate of 58.4 percent in the combination compared to 35 percent on chemotherapy alone.
Roche will also be presenting data at ASCO from its Phase III IMpower150 study of Tecentriq (atezolizumab) and Avastin (bevacizumab) plus carboplatin and paclitaxel (chemotherapy) for the first-line treatment of chemotherapy-naïve patients with metastatic non-squamous NSCLC. In an early analysis, Sandra Horning, Roche’s chief medical officer and head of Global Product Development, stated, “The IMpower150 study results showed a significant survival benefit, adding to the clinical evidence supporting the combination of Tecentriq and Avastin as an initial treatment for metastatic non-squamous non-small cell lung cancer. An overall survival benefit was also observed in key populations such as people with EGFR- and ALK-positive mutations and those with liver metastases.”
At this point, Merck’s Keytruda is the only immunotherapy approved in the U.S. for lung cancer patients who have not received prior treatment. Squamous cell NSCLC makes up about 30 percent of all lung cancers. Patients diagnosed with squamous cell lung cancer generally have a poor prognosis because it is usually diagnosed after it has spread.
All the news may not be good, however. The FDA recently warned physicians, trial investigators and the public last Friday that Merck’s Keytruda and Roche’s Tecentriq showed some warning signs in recent trials in bladder cancer. Oversight committees observed in both studies that patients with low PD-L1 biomarker levels treated with the immunotherapies had decreasing survival chances compared to those who took platinum chemotherapy. Both drugs have conditional approval for certain bladder cancers in treatment-naïve patients. Regulators are asking doctors and patients to report any side effects related to either drug. They’re also encouraging healthcare providers to adhere to the drugs’ labels when prescribing.
Novus progressing toward otitis media therapy
Shares of Novus Therapeutics ( NVUS ) are up an impressive 47% so far this month while the iShares Nasdaq Biotechnology Index (ETF)(IBB) is up a mere 3% for the same period.
Novus is a development stage specialty pharmaceutical company focused on developing products for disorders of the ear, nose, and throat.
The lead product is OP-02, a drug-device product being developed as a first-in-class treatment option for otitis media, which has a global incidence of over 700 million cases every year.
Otitis media (OM) is an umbrella term that refers to a group of inflammatory diseases of the middle ear like Acute otitis media or “AOM” (inflammation with infectious fluid); Otitis media with effusion or “OME” (inflammation with non-infectious fluid) and Chronic suppurative otitis media or “CSOM” (eardrum perforation with persistent drainage).
The global market for Acute Otitis Media treatment, which was valued at $2.04 billion in 2016, is projected to exceed $3.2 billion by 2025, according to recent report by Coherent Market Insights.
Although Acute Otitis Media can resolve on its own, antibiotics and surgery are the treatment options for it.
Novus’ OP-02 has successfully completed pre-clinical studies, and the Company is planning to initiate its first-in-human clinical studies with OP-02 in healthy adults in the second half of 2018.
A phase I study of OP-02 in children with otitis media with effusion, and a phase I study in adults with acute otitis media are expected to be initiated in the first half of 2019. Top line data from the phase I studies are expected in the first half of 2019.
Also in the pipeline is OP-01, a foam treatment for Acute Otitis Externa, or “swimmer’s ear”.
Acute Otitis Externa is a common condition of the external ear canal involving inflammation and infection. The current market leader in the ear anti-infective market is CIPRODEX, marketed by Alcon.
The Company had tested the first generation formulation of OP-O1 in a phase II trial, and the safety and efficacy data announced in January 2015, demonstrated that OP-O1 is similar (non-inferior) to CIPRODEX.
*Key Numbers…
Accumulated deficit: $30.3 million
Cash: $22.5 million
(*As of Mar.31, 2018)
NVUS touched a yearly high of $6.97 on May 21, 2018. The stock closed yesterday’s trading at $6.66, down 4% from its 52-week high.
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