Bromhexine Hydrochloride

April 18, 2017 By Alex Keown , BioSpace.com Breaking News Staff SEOUL – South Korea-based Hanmi Pharmaceuticals failed to report in a timely manner a patient death that occurred during clinical trials of tis lung cancer drug olmutinib—the same drug that Boehringer Ingelheim walked away from last year. This morning The Korea Herald reported that Hanmi had violated two medical laws regarding the monitoring and reporting of its clinical trials. The Board of Audit and Inspection of Korea began its investigation following allegations aimed by Korea lawmakers against Hanmi that it failed to announce the clinical trial death in order to gain regulatory approval of the drug last year. It was that death, along with two other deaths that caused Boehringer Ingelheim to walk away from the $730 million developmental deal with Hanmi. According to reports, one of the patients in the trial treated with Hanmi’s lung cancer drug displayed symptoms of Stevens-Johnson syndrome, a life-threatening skin-condition. The patient’s condition was not reported to the monitoring agency until his death more than a month later–a violation of Korea’s 24-hour reporting rule for severe incidents, the Herald said. But, to make matters worse, Hanmi and the monitoring agency did not report the death to health regulators for another 14 months. Hanmi issued a statement in an attempt to explain the delayed reporting, saying the company had some shortcomings in reporting protocols. The company also said the patient had been taking two additional cancer medications, bromhexine and tiocr, which have side effects of Stevens-Johnson syndrome. Hanmi said medical staff believe those two drugs were the cause of the death and not olmutinib. Hanmi said the trial monitor classified the development of Stevens-Johnson as a “serious event” and not as a “serious unexpected serious adverse reaction,” which requires immediate reporting, the Herald said. In its statement, Hanmi said it became aware of the Stevens-Johnson-related death and its possible link to olmutinib during a data review one year later and then reported the death. In October 2016, Boehringer Ingelheim walked away from its partnership with Hanmi. At the time, the company said it did not believe olmutinib would be a competitive drug in the lung cancer market. However, also at the time, Pharma Live reported that Boehringer terminated the licensing deal following the death of two patients who developed “serious skin reactions.” Dosage was cut back to reduce toxicity risks, but that also caused a drop in the efficacy of olmutinib, according to reports. While Hanmi and Boehringer Ingelheim have severed their relationship, the South Korean company has a deal worth more than $900 million with Genentech to develop another cancer drug , a pan-RAF inhibitor. In addition to the deal with Genentech , Hanmi also has a deal with Johnson & Johnson ’s Janssen Pharmaceuticals to develop and commercialize oxyntomodulin-based drugs that improve metabolism, insulin secretion and suppress appetite. Shares of Hanmi are trading at $28.60 this morning.

December 15, 2015 By Mark Terry , BioSpace.com Breaking News Staff After weeks of hints and speculation that Paris-based Sanofi was considering spinning off its animal health unit, Merial , the company announced its plans—just not the way everyone expected. Sanofi announced today that it was entering into exclusive negotiations for a business swap with Ingelheim , Germany-based Boehringer Ingelheim . Sanofi would trade Merial for Boehringer Ingelheim ’s consumer healthcare (CHC) business. Merial has an enterprise value of €11.4 billion, and Boehringer ’s CHC has an enterprise value of €6.7 billion. Boehringer ’s CHC China business would not be part of the deal. In addition, Boehringer would pay Sanofi €4.7 billion. Merial employs 6,600 individuals and runs in more than 150 countries. It has three main segments, products for pets, farm animals and veterinary public health. “In entering into exclusive negotiations with Boehringer Ingelheim , we have acted swiftly to meet one of the key strategic objectives of our roadmap 2020, namely to build competitive positions in areas where we can achieve leadership,” said Olivier Brandicourt , Sanofi ’s chief executive officer, in a statement. “This transaction would allow Sanofi to become a world leader in the attractive non-prescription medicines market and would bring a complementary portfolio with highly recognized brands, allowing for mid and long term value creation.” The deal is expected to close in the fourth quarter of 2016. Sanofi hasn’t made any deals since 2011, when it acquired Genzyme for $20.1 billion. As part of the deal Sanofi ’s name brands Maalox and Lactacyd will become part of Boehringer ’s portfolio, which includes cough medicines Mucosolvan and Bisolvon. Sanofi gains a bigger market presence in Germany and Japan, two areas where it is currently limited. The combined animal health units will have annual sales of about €3.8 billion. Merial ’s bigger products include Frontline, Heartgard and GastroGard. Boehringer ’s products include Circoflex and Metacam. In 2011, Sanofi gave up on its plans to merge its animal health business with Merck & Co. ’s, indicating that it was too complex of a deal. This new deal has some similarities to last year’s asset swap between GlaxoSmithKline Plc and Novartis . That was part of a three-way deal in which GSK acquired Novartis ’s vaccines business, excluding influenza vaccines, the development of a consumer healthcare joint venture, and the sale of GSK ’s oncology portfolio related to research-and-development activities and rights to two AKT inhibitors to Novartis . Sanofi has also indicated that it will use cash from the deal to buy back shares. This, according to Reuters, will make “the planned transaction neutral to earnings in 2017 and accretive thereafter.” Brandicourt took over Sanofi in April of this year after the company’s chief executive officer, Chris Viehbacher , was ousted by the board. Analysts in general have been waiting for something dramatic from Brandicourt, and appear to have gotten their wish. “The new CEO has clearly started to put his stamp on the company,” analysts at Barclays wrote in a note, “and isn’t afraid or impeded from taking strategic action.” “ Boehringer Ingelheim ’s strategic priority is to focus on the company’s core areas of expertise and businesses with an established global scale, or where a pathway to a global scale can be achieved and prioritized among Boehringer Ingelheim ’s portfolio opportunities,” said Andreas Barner , Boehringer ’s chairman of the board, in a statement. “ Boehringer Ingelheim Animal Health is and will stay strongly committed to bringing novel, innovation driven solutions to veterinarians and animal owners. Our combined Animal Health business would be well positioned for growth and emergence as a leader globally.”