Monday, October 1, 2018
Adial Pharmaceuticals initiated at Dawson James
Dawson James initiated Adial Pharmaceuticals with a Buy and $6 price target.
https://thefly.com/landingPageNews.php?id=2797973
Chiasma completes enrollment for phase 3 CHIASMA OPTIMAL trial
Chiasma announced that it has completed enrollment of its international Phase 3 clinical trial, referred to as CHIASMA OPTIMAL. This trial is being conducted under a special protocol assessment, or SPA, agreement with the FDA to support potential regulatory approval in the United States of its investigational octreotide capsules, conditionally trade-named Mycapssa, for the maintenance therapy of adult patients with acromegaly. Chiasma exceeded target enrollment of 50 patients in the trial with a total of 56 acromegaly patients randomized in 17 countries worldwide, including 21 patients from the U.S.
https://thefly.com/landingPageNews.php?id=2798007
AmerisourceBergen to pay $625M to end charges of distributing unapproved drugs
AmerisourceBergen (ABC +0.7%) has agreed to pay 44 states and the federal government $625M to settle civil charges of distributing unapproved and adulterated drugs related to the alleged misbehavior of an Alabama pharmacy owned by subsidiary AmerisourceBergen Specialty Group (ABSG). It seems that the pharmacy in question was behind a number of false Medicaid claims for unapproved new drugs and defective, contaminated or otherwise compromised medications. There were also instances of double billing for the same product.
The pharmacy supposedly repackaged vials of certain drugs into pre-filled syringes which it shipped to oncology practices and doctors treating cancer patients. The “overfill” scheme enabled the pharmacy to boost profits from the vial formulations, but represented increased risk to patients since the activities were performed in an unsterile environment which resulted in a number of cases of contaminated product.
ABSG agreed to pay $260M in criminal fines and forfeitures.
Novartis-backed cell therapy startup Gamida files for IPO
Gamida Cell has filed to raise $69 million in a Nasdaq IPO. The Novartis-backed cell therapy player wants the money to wrap up a phase 3 trial of its lead candidate in patients with blood cancers.
Cell therapies, in the form of hematopoietic stem cell transplantations (HSCT), are already widely used in the treatment of blood cancers such as acute myeloid leukemia. However, the number of patients who receive HCST is limited by a lack of donor-matched cells. Haploidentical donors and umbilical cord blood partly make up for the shortfall in donor-matched cells, but Gamida still thinks 40% of patients eligible for HSCT never receive the treatment.
Gamida wants to enable these patients to access cell therapy treatments. The biotech’s answer to the problem, NiCord, is made by applying a nicotinamide-based cell expansion technology to cord blood. Gamida thinks the result is an off-the-shelf treatment consisting of cells that quickly engraft and largely avoid attack by the host immune system.
Israel-based Gamida is enrolling patients in a phase 3 trial to test the idea. With the trial not due to deliver top-line data until the first half of 2020 and Gamida’s cash reserves dipping below $30 million, the biotech is seeking up to $69 million from public investors to complete the study.
Some of the money will go toward the build-out of a manufacturing plant in Israel. Manufacturing has posed challenges for the company. During a recent audit of Gamida’s contract manufacturer, Israeli inspectors made critical observations. Gamida is working with the manufacturer to fix the issues but is yet to get the all-clear from regulators.
Novartis was set to buy Gamida for $170 million upfront in 2014, but the deal fell through. Later that year, Novartis invested $35 million in Gamida and secured an option to buy the biotech outright in 2016. However, Novartis turned down the option 10 months later, well before it was due to expire.
The Swiss Big Pharma has continued to invest in Gamida, though. Novartis invested $5 million late in 2015—after turning down its option—and put a further $8 million into Gamida last year. The rounds left Novartis owning more than one-fifth of Gamida, making it the biotech’s biggest shareholder.
Trump Signs Funding Bill Giving NIH $2B Boost in FY19
President Donald Trump on Friday signed into law an appropriations package that included a $2 billion budget increase in fiscal year 2019 for the National Institutes of Health.
The bipartisan legislation increases the NIH’s budget by 5.4 percent over its fiscal 2018 funding level to $39.1 billion. The bill passed the House by a vote of 361 to 61 and passed the Senate in a 93-to-7 vote. It specifically includes an additional $425 million for Alzheimer’s disease research for a total of $2.34 billion; a total of $429.4 million for the BRAIN initiative, a $29 million increase; and $376 million for the All of Us precision medicine study, $86 million more than in FY 2018.
Perrigo confirms patent challenge for generic version of Jublia
Perrigo Company announced that Valeant Pharmaceuticals North America, Valeant Pharmaceuticals Ireland, Dow Pharmaceuticals Sciences and Kaken Pharmaceuticals initiated patent litigation on September 21, 2018 in the United States District Court for the District of New Jersey regarding Perrigo’s Paragraph IV Abbreviated New Drug Application for efinaconazole topical solution 10%, asserting patents listed in the Orange Book for Jublia. This action formally initiates the litigation process under the Hatch-Waxman Act. Jublia Topical Solution 10%, is indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum and Trichophyton mentagrophytes. Annual market sales for the 12 months ending July 2018 were $276M as measured by IQVIA.
https://thefly.com/landingPageNews.php?id=2797857
Seattle Genetics, Takeda: Positive Phase 3 T-Cell Lymphoma Med Results
-ADCETRIS in Combination with Chemotherapy Achieved Primary Endpoint, Demonstrating a Statistically Significant Improvement in Progression-Free Survival Compared to a Standard of Care Chemotherapy-
-Statistically Significant Improvement Achieved in All Key Secondary Endpoints, Including Overall Survival-
-First Randomized Phase 3 Trial to Show Improvement in Overall Survival in Frontline Peripheral T-Cell Lymphoma-
-Data to be Presented at the 2018 ASH Annual Meeting; Global Regulatory Submissions Planned-
Seattle Genetics, Inc. (Nasdaq:SGEN) and Takeda Pharmaceutical Company Limited (TSE:4502) announced today that the phase 3 ECHELON-2 clinical trial met its primary endpoint. The trial demonstrated a statistically significant improvement in progression-free survival (PFS) of ADCETRIS (brentuximab vedotin) in combination with CHP (cyclophosphamide, doxorubicin, prednisone) versus the control arm, CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone). ECHELON-2 is a global, randomized, double-blind, multicenter trial evaluating ADCETRIS as part of a frontline combination chemotherapy regimen in patients with previously untreated CD30-expressing peripheral T-cell lymphoma (PTCL), also known as mature T-cell lymphoma (MTCL). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed on the surface of several types of PTCL. ADCETRIS is currently not approved for the frontline treatment of PTCL.
Patients in ECHELON-2 were randomized to receive either a combination of ADCETRIS plus CHP or CHOP, a recognized standard of care for frontline PTCL. Results from the trial demonstrated that combination treatment with ADCETRIS plus CHP was superior to the control arm for PFS as assessed by an Independent Review Facility (IRF; hazard ratio=0.71; p-value=0.0110). The ADCETRIS plus CHP arm also demonstrated superior overall survival (OS), a key secondary endpoint, compared to CHOP (hazard ratio=0.66; p-value=0.0244). All other key secondary endpoints, including PFS in patients with systemic anaplastic large cell lymphoma (sALCL), complete remission rate and objective response rate were statistically significant in favor of the ADCETRIS plus CHP arm. The safety profile of ADCETRIS plus CHP in the ECHELON-2 trial was comparable to CHOP and consistent with the established safety profile of ADCETRIS in combination with chemotherapy. Additional data will be presented at the American Society of Hematology (ASH) 2018 annual meeting, December 1-4, 2018, in San Diego, California.
“Peripheral T-cell lymphoma is an aggressive type of non-Hodgkin lymphoma with approximately 4,000 CD30-expressing patients diagnosed every year in the United States,” said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “We are excited about the groundbreaking results of the phase 3 ECHELON-2 clinical trial, which demonstrated ADCETRIS in combination with chemotherapy significantly improved treatment outcomes for adult patients with previously untreated CD30-expressing PTCL compared with the current standard of care (CHOP). We’d like to thank the many investigators and patients who participated in this study and contributed to this significant milestone for the PTCL community. We look forward to presenting results at the ASH annual meeting in December and intend to submit a supplemental Biologics License Application to the FDA for approval in this setting in the near future.”
“These clinically meaningful results from ECHELON-2 represent a significant step in the development of a potential frontline treatment in this disease. This trial is the largest randomized, double-blind, phase 3 trial in PTCL,” said Jesús Gomez-Navarro, M.D., Vice President, Head of Oncology Clinical Research and Development, Takeda. “Standard of care in PTCL has not changed in several decades and there remains an unmet need for patients. These data showed a significant improvement in the primary endpoint of progression-free survival and all key secondary endpoints, including overall survival, along with a manageable safety profile. We look forward to sharing these data with regulatory authorities globally.”
Takeda and Seattle Genetics plan to submit these results to regulatory authorities for approval in their respective territories.
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