On September 1, 2016 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported positive results for TECENTRIQ from the Phase III study, OAK (Press release, Genentech, SEP 1, 2016, View Source [SID:1234514850]). The study met its co-primary endpoints and showed a statistically significant and clinically meaningful improvement in overall survival (OS) compared with docetaxel chemotherapy in people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease progressed on or after treatment with platinum-based chemotherapy. Adverse events were consistent with what has been previously observed for TECENTRIQ. Genentech looks forward to presenting full results at an upcoming medical meeting in 2016. Schedule your 30 min Free 1stOncology Demo! "These results add to the growing body of evidence that supports the role of TECENTRIQ as a potential new treatment for specific types of advanced NSCLC," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "This is very encouraging news for people living with this disease because lung cancer is the leading cause of cancer deaths around the world. We hope to bring this treatment option to patients as soon as possible."
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The FDA granted Breakthrough Therapy Designation (BTD) for TECENTRIQ for the treatment of people with PD-L1 (programmed death-ligand 1) positive NSCLC whose disease has progressed during or after platinum-based chemotherapy (and appropriate targeted therapy for those with an EGFR mutation-positive or ALK-positive tumor). Genentech’s Biologics License Application (BLA) for NSCLC was granted Priority Review with an action date of Oct. 19, 2016.
Genentech has eight Phase III lung studies underway evaluating TECENTRIQ alone or in combination with other treatments in people with early and advanced stages of lung cancer.
About the OAK study
OAK is a Phase III, global, multicenter, open-label, randomized, controlled study evaluating the efficacy and safety of TECENTRIQ compared with docetaxel in people with locally advanced or metastatic NSCLC whose disease progressed on or after treatment with platinum-containing chemotherapy.
The study’s co-primary endpoints were overall survival in:
All people randomized to treatment in the study (intention-to-treat or ITT population), and
a PD-L1 selected subgroup of people
PD-L1 expression was assessed on both tumor cells (TC) and tumor-infiltrating cells (IC) with an investigational immunohistochemistry (IHC) test based on the SP142 antibody being developed by Roche Tissue Diagnostics, and was defined as people whose tumors were determined to express PD-L1 with an IHC score of TC1/2/3 or IC1/2/3.
Secondary endpoints included objective response rate (ORR), progression-free survival (PFS), duration of response (DOR) and safety.
A total of 1,225 patients were enrolled and randomized 1:1 to receive either docetaxel (75 mg/m2 intravenous infusion) or TECENTRIQ (1200 mg intravenous infusion) every three weeks. Treatment on TECENTRIQ continued as long as patients experienced clinical benefit as assessed by the investigator or until unacceptable toxicity. The primary efficacy analysis was based on the first 850 randomized patients, and the secondary efficacy analysis will include all 1,225 randomized patients.
About non-small cell lung cancer
According to the American Cancer Society, it is estimated that more than 224,000 Americans will be diagnosed with lung cancer in 2016, and NSCLC accounts for 85 percent of all lung cancers. It is estimated that approximately 60 percent of lung cancer diagnoses in the United States are made when the disease is in the advanced stages.
About TECENTRIQ (atezolizumab)
TECENTRIQ is a monoclonal antibody designed to bind with a protein called PD-L1. TECENTRIQ is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, TECENTRIQ may enable the activation of T cells. TECENTRIQ may also affect normal cells.
TECENTRIQ is the first and only anti-PD-L1 cancer immunotherapy approved by the FDA, and is indicated for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). This indication for TECENTRIQ is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
TECENTRIQ U.S. Indication (pronounced ‘tē-SEN-trik’)
TECENTRIQ is a prescription medicine used to treat:
A type of bladder cancer called urothelial carcinoma. TECENTRIQ may be used when bladder cancer has spread or cannot be removed by surgery (advanced urothelial carcinoma) and,
The patient has tried chemotherapy that contains platinum, and it did not work or is no longer working.
It is not known if TECENTRIQ is safe and effective in children.
Important Safety Information
Important Information About TECENTRIQ
TECENTRIQ can cause the immune system to attack normal organs and tissues in many areas of the body and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death.
Getting medical treatment right away may help keep these problems from becoming more serious. The healthcare provider may treat the patient with corticosteroid or hormone replacement medicines. The healthcare provider may delay or completely stop treatment with TECENTRIQ if severe side effects occur.
Patients should call or see their healthcare provider right away if they get any symptoms of the following problems or these symptoms get worse.
TECENTRIQ can cause serious side effects, including:
Lung Problems (pneumonitis) – Signs and symptoms of pneumonitis may include: new or worsening cough, shortness of breath, or chest pain
Liver Problems (hepatitis) – Signs and symptoms of hepatitis may include: yellowing of the skin or the whites of the eyes, severe nausea or vomiting, pain on the right side of the stomach area (abdomen), drowsiness, dark urine (tea colored), bleeding or bruising more easily than normal, feeling less hungry than usual
Intestinal Problems (colitis) – Signs and symptoms of colitis may include: diarrhea (loose stools) or more bowel movements than usual, blood in the stools or dark, tarry, sticky stools, severe stomach area (abdomen) pain or tenderness
Hormone Gland Problems (especially the pituitary, thyroid, adrenal glands and pancreas) – Signs and symptoms that the hormone glands are not working properly may include: headaches that will not go away or unusual headaches, extreme tiredness, weight gain or weight loss, dizziness or fainting, feeling more hungry or thirsty than usual, hair loss, changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness, feeling cold, constipation, voice gets deeper, urinating more often than usual, nausea or vomiting, stomach area (abdomen) pain
Nervous System Problems (neuropathy, meningoencephalitis) – Signs of nervous system problems may include: severe muscle weakness, numbness or tingling in hands and feet, fever, confusion, changes in mood or behavior, extreme sensitivity to light, neck stiffness
Inflammation of the Eyes – Symptoms may include blurry vision, double vision, other vision problems, eye pain or redness
Severe Infections – Symptoms of infection may include: fever, cough, frequent urination, flu-like symptoms, pain when urinating
Severe Infusion Reactions – Signs and symptoms of infusion reactions may include: chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, fever, feeling like passing out, back or neck pain, facial swelling
The most common side effects of TECENTRIQ include:
feeling tired
decreased appetite
nausea
urinary tract infection
fever
constipation
These are not all the possible side effects of TECENTRIQ. Patients should ask their healthcare provider or pharmacist for more information.
Before receiving TECENTRIQ, patients should tell their healthcare provider about all of their medical conditions, including if they:
have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus; have had an organ transplant; have lung or breathing problems; have liver problems; have a condition that affects the nervous system, such as Myasthenia Gravis or Guillain-Barre syndrome; or are being treated for an infection.
are pregnant or plan to become pregnant.
TECENTRIQ can harm an unborn baby.
If patients are able to become pregnant, they should use an effective method of birth control during treatment and for at least 5 months after the last dose of TECENTRIQ.
are breastfeeding or plan to breastfeed.
It is not known if TECENTRIQ passes into the breast milk.
Do not breastfeed during treatment and for at least 5 months after the last dose of TECENTRIQ.
Patients should tell their healthcare provider about all of the medicines they take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
Report side effects to the FDA at (800) FDA-1088, or View Source Report side effects to Genentech at (888) 835-2555.
Please visit View Source for the TECENTRIQ full Prescribing Information for additional Important Safety Information.
Amgen obtains global development and commercial rights from Boehringer Ingelheim for investigational BiTE® immuno-oncology drug for multiple myeloma
On September 1, 2016 Amgen (NASDAQ:AMGN) and Boehringer Ingelheim reported that Amgen has acquired global development and commercial rights from Boehringer Ingelheim for BI 836909 (AMG 420), a bispecific T cell engager (BiTE) that targets B-cell maturation antigen (BCMA), a potential target for multiple myeloma (Press release, Boehringer Ingelheim, AUG 31, 2016, http://us.boehringer-ingelheim.com/news_events/press_releases/press_release_archive/2016/9-1-2016-amgen-obtains-global-development-commercial-rights-boehringer-ingelheim-investigational-bite-immuno-oncology-drug-multiple-myeloma.html [SID:1234514869]). BI 836909 (AMG 420) is currently in Phase 1 studies. BI 836909 (AMG 420) was originally licensed to Boehringer Ingelheim by Micromet before the company was acquired by Amgen in 2012.
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Under the provisions of the agreement, Amgen will work with Boehringer Ingelheim to assume responsibility for the clinical development of BI 836909 (AMG 420), transfer manufacturing, and lead global regulatory activity moving forward. Amgen will also receive worldwide commercialization rights for BI 836909 (AMG 420). Prior to this agreement, Boehringer Ingelheim held global development and commercialization rights. Financial terms of the agreement are not being disclosed.
"Obtaining global rights to BI 836909 (AMG 420) advances Amgen’s immuno-oncology strategy allowing us to leverage our expertise with the BiTE platform to target BCMA in the multiple myeloma setting," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Multiple myeloma is a rare and aggressive blood cancer and despite new advances there is currently no cure. BI 836909 (AMG 420) allows us to explore a potential new treatment approach that harnesses the immune system to fight multiple myeloma."
"Boehringer Ingelheim is delighted that Amgen will continue our successful development of this important compound for multiple myeloma," said Dr. Jörg Barth, corporate senior vice president, Therapy Area Head Oncology at Boehringer Ingelheim. "Given Amgen’s focus in this disease area, we are convinced this best supports the future development for BI 836909 (AMG 420) and the goal to ultimately offer new treatment options for patients. Immuno-oncology and T cell engagers remain a key area of focus for Boehringer Ingelheim as well as providing innovative treatments for lung and blood cancers."
About BI 836909 (AMG 420)
BI 836909 (AMG 420) is a bispecific T cell engager (BiTE) that is under investigation for the treatment of multiple myeloma. BI 836909 (AMG 420) targets B-cell maturation antigen (BCMA), a target in multiple myeloma due to its restricted normal tissue expression and uniform expression on multiple myeloma cells. BI 836909 (AMG 420) is currently being evaluated in Phase 1 studies.
About BiTE Technology
Bispecific T cell engager (BiTE) antibody constructs are a type of immunotherapy being investigated for fighting cancer by helping the body’s immune system to detect and target malignant cells. The modified antibodies are designed to engage two different targets simultaneously, thereby juxtaposing T cells (a type of white blood cell capable of killing other cells perceived as threats) to cancer cells. BiTE antibody constructs help place the T cells within reach of the targeted cell, with the intent of allowing T cells to inject toxins and trigger the cancer cell to die (apoptosis). BiTE antibody constructs are currently being investigated for their potential to treat a wide variety of cancers. For more information, visit www.biteantibodies.com.
Chugai Transfers the Manufacturing and Marketing Rights of VESANOID® to Fuji Pharma
On August 31, 2016 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) and Fuji Pharma Co., Ltd. (TOKYO: 4554) reported that they agreed to transfer the rights to manufacture and market VESANOID (generic name: tretinoin, brand name: VESANOID capsule 10mg) in Japan for the indication of acute promyelocytic leukemia (APL), from Chugai to Fuji Pharma effective on November 1, 2016.
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VESANOID is an orally available vitamin A derivative for the treatment of APL developed by Roche. In Japan, VESANOID was designated as orphan drug by the Minister of Health, Labour and Welfare, in 1993 and has been on the market since March 1995.
In order to ensure the constant supply of VESANOID, Chugai continues to distribute the product in the interim. Once all Chugai labeled products have been sold to the market, the distribution of Fuji Pharma labeled products will be implemented.
Chugai and Fuji Pharma will cooperate to accomplish a smooth transition of manufacturing and marketing of VESANOID, together by delivering products and their information meeting medical needs, as well as promoting the appropriate use of VESANOID.
In April 2016, the business transfer agreement for VESANOID to manufacture and market in Japan was concluded among Cheplapharm Arzneimittel GmbH, Roche and Chugai. Cheplapharm acquired the manufacturing and marketing rights of VESANOID in Japan and licensed out those rights to Fuji Pharma.
Sunovion Pharmaceuticals to Acquire Cynapsus Therapeutics
On August 31, 2016 Sunovion Pharmaceuticals Inc. (Sunovion) and Cynapsus Therapeutics Inc. (Cynapsus) (NASDAQ: CYNA) (TSX: CTH) reported that the companies have signed a definitive agreement under which Sunovion will acquire Cynapsus for US$40.50 per share in cash (Press release, Sunovion, AUG 31, 2016, View Source [SID:1234514849]). The transaction has received unanimous approval by the Board of Directors of both companies and values Cynapsus at approximately US$624 million (or approximately CAN$820 million). The acquisition will be funded with cash on hand. The transaction is expected to close in the fourth quarter of 2016 (third quarter of Sunovion’s fiscal year). This agreement reflects Sunovion’s global strategy to expand and diversify its portfolio in key therapeutic areas, including neurology.
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Through this transaction, Sunovion would acquire Cynapsus’ product candidate, APL-130277, which is designed to be a fast-acting, easy-to-use, on-demand treatment option for managing OFF episodes associated with Parkinson’s disease (PD).
"Parkinson’s disease is a chronic, progressive neurodegenerative disease that affects more than four million people around the world, and there is a significant need for new options to treat the OFF episodes associated with it," said Nobuhiko Tamura, Chairman and Chief Executive Officer, Sunovion. "We believe that APL-130277 is a novel late-stage candidate with the potential to make a real difference for patients and their families."
"The acquisition of Cynapsus is well-aligned with Sunovion’s focus on the innovative application of science and medicine to help people with serious medical conditions and complements our robust product pipeline," added Mr. Tamura. "We have high regard for the Cynapsus team and their work with the APL-130277 program."
"With its leadership in therapies for central nervous system disorders and commercial experience specific to neurology, we believe Sunovion is best suited to advance APL-130277 in the United States and other key markets," said Anthony J. Giovinazzo, President and CEO, Cynapsus. "This transaction culminates years of dedicated work by the Cynapsus team and represents significant value creation for our securityholders."
The board of directors of Cynapsus, after consultation with its financial and legal advisors and based, in part, upon the unanimous recommendation of an independent special committee of the board of directors, has determined that the arrangement is in the best interest of Cynapsus and the consideration to be received by shareholders of Cynapsus is fair to such shareholders. The board of directors unanimously recommends that Cynapsus shareholders and warrantholders vote in favour of the transaction at a special meeting expected to be held on or about October 13, 2016.
The proposed sale of Cynapsus follows a full consideration of alternatives aimed at optimizing shareholder value for the company. "We believe that the proposed transaction with Sunovion results in the best outcome for our shareholders," said Rochelle Stenzler, chair of the board of Cynapsus. "The transaction with Sunovion represents a significant premium to the current share price and we are recommending that our shareholders and warrantholders vote in favour of the transaction."
Pursuant to the terms of the definitive agreement, upon closing of the proposed transaction, shareholders of Cynapsus will receive US$40.50 per common share in cash, and holders of warrants and stock options will receive a cash payment equal to the difference between US$40.50 and the exercise price of such warrant or stock option. The offer of US$40.50 per common share in cash represents a premium of 123 percent based on the volume weighted average closing price of Cynapsus’ common shares on the NASDAQ Global Market for the last twenty trading days. The companies expect to close the transaction following required securityholder, court and regulatory approvals and satisfaction of certain other customary closing conditions.
The transaction will be completed by way of a plan of arrangement under the Canada Business Corporations Act. The arrangement will require approval of at least two-thirds of the votes cast by Cynapsus shareholders and warrantholders voting together as a single class at a special meeting of such securityholders of Cynapsus. Voting and Support Agreements in support of the transaction have been signed by all directors and officers of Cynapsus and the company’s largest shareholder representing in the aggregate, approximately 18.33 percent of the Cynapsus securities entitled to vote to approve the transaction.
Full details of the transaction will be included in the management information circular to be filed with the applicable securities regulatory authorities and mailed to Cynapsus shareholders and warrant holders within approximately two weeks. Assuming receipt of all required regulatory approvals, the parties expect to close the arrangement in the fourth quarter of 2016.
BofA Merrill Lynch serves as financial advisor, and Borden Ladner Gervais LLP and Troutman Sanders LLP serve as legal advisors to Cynapsus. Stifel, Nicolaus & Company, Incorporated serves as financial advisor and Fasken Martineau DuMoulin LLP serves as a legal advisor to the Special Committee of Cynapsus. Nomura Securities International, Inc. serves as exclusive financial advisor, and Goodmans LLP, Reed Smith LLP, and Gibbons PC serve as legal advisors to Sunovion.
Adagio Amending Agreement
Cynapsus and the former shareholders of Adagio Pharmaceuticals Ltd. ("Adagio") entered into a share purchase agreement dated as of December 22, 2011, as subsequently amended as of January 28, 2015 (the "Share Purchase Agreement"), pursuant to which Cynapsus acquired Adagio.
Cynapsus and the former shareholders of Adagio have amended the Share Purchase Agreement to provide, among other things, that if a change of control of Cynapsus, which would include the transaction with Sunovion, occurs before the successful completion and the first public announcement of the top-line data of the Final Safety Study (as defined in the Share Purchase Agreement), the CDN$2,500,000 of the purchase price still potentially payable to the former shareholders of Adagio shall be paid in cash (not common shares, as was originally contemplated in the Share Purchase Agreement) by Cynapsus, on the date on which the change of control transaction is completed.
As Anthony Giovinazzo, President and Chief Executive Officer of Cynapsus, is also a director, officer and majority shareholder of Adagio, the amendment of the Share Purchase Agreement constitutes a related party transaction pursuant to Multilateral Instrument 61-101 and the policies of the TSX. The amendment was necessary, and appropriate, as it ensures that if Sunovion acquires all of the common shares of Cynapsus, it would not have an obligation to potentially issue shares to the former Adagio shareholders post-closing of such acquisition. The amendment was entered into at the same time as the arrangement agreement with Sunovion and therefore was not announced more than 21 days before its execution.
About APL-130277
APL-130277, a novel formulation of apomorphine, a dopamine agonist, is being developed as a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with Parkinson’s disease. Apomorphine is the only molecule approved for acute, intermittent treatment of OFF episodes for advanced PD patients, but is currently only approved as a subcutaneous injection in the United States. APL-130277 is designed to rapidly, safely and reliably convert a PD patient from the OFF to the ON state while avoiding many of the issues associated with subcutaneous delivery of apomorphine. It has been studied in all types of OFF episodes, including morning OFF episodes. APL-130277 is in Phase 3 clinical trials and has not been approved by the U.S. Food and Drug Administration (FDA).
In the ongoing Phase 3 trial, CTH-300, the blinded safety data was corroborated by the DSMB findings, which were announced in the press release dated August 15, 2016. If the ongoing pivotal Phase 3 clinical trials are successful, it is expected that a New Drug Application (NDA) for APL-130277 will be submitted to the U.S. Food and Drug Administration (FDA) during the first half of 2017 under the abbreviated Section 505(b)(2) regulatory pathway. A pivotal European clinical program evaluating the safety and efficacy of APL-130277 in PD patients is expected to be initiated in the fourth quarter of 2016.
OPKO Health Completes Acquisition of Transition Therapeutics
On OPKO Health, Inc. (NASDAQ: OPK), reported that it has completed its previously announced acquisition of Transition Therapeutics, Inc. (NASDAQ: TTHI, TSX: TTH), by way of a plan of arrangement (the "Arrangement") which was approved by Transition Therapeutics’ shareholders at their meeting held on August 25, 2016 (Press release, Opko Health, AUG 31, 2016, View Source [SID:1234514848]). Pursuant to the Arrangement, shareholders of Transition Therapeutics will receive an aggregate of approximately 6.4 million shares of OPKO common stock, or 0.1657 shares of OPKO common stock for each common share of Transition Therapeutics. The Arrangement was approved by the Ontario Superior Court of Justice in its final order dated August 29, 2016.
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"We are pleased to complete the acquisition of Transition Therapeutics as it provides us with two late-stage drug candidates, each of which holds exceptional market opportunity and has direct synergies with our clinical development pipeline," said Phillip Frost, M.D., CEO and Chairman of OPKO Health. "With the transaction complete, we look forward to advancing these promising programs to the benefit of patients suffering from Type II diabetes and obesity or certain male hormone related problems."