What does today's oncology's drugs advisory panel meet mean for Biocon? CLSA explains

The committee will discuss biosimilarity of the product and label extrapolation application by Mylan/Biocon given that they have conducted clinical trials on only one of the three indications, said CLSA.

CLSA has recommended sell rating on Biocon. The oncology drugs advisory committee meeting is scheduled to be held today to discuss Mylan/Biocon’s Trastuzumab US filing.
The committee will discuss biosimilarity of the product and label extrapolation application by Mylan/Biocon given that they have conducted clinical trials on only one of the three indications, said CLSA.
The advisory committee will vote on all discussions and explain their reasons for the same, post which it may recommend the USFDA to approve the product (with or without extrapolation) or it may reject the filing, it added.
A favourable vote from the committee will be a positive development for Mylan/Biocon but it would not mean an approval. The committee can only guide the US FDA, which takes the final call on the product filing and the plant compliance status at the time of approval.
The biosimilar manufacturing plant in Bangalore was inspected by the US FDA in Mar/Apr-17 with 8 observations and by the EU regulator with 35 observations. These observations are still unresolved and may lead to approval delays or denial, CLSA added.
Assuming a US launch in early CY19 and EU launch in 2HCY18, research firm estimate the Trastuzumab opportunity at Rs 52 per share on an NPV basis.
At 10:18 hrs Biocon was quoting at Rs 365, down Rs 2.30, or 0.63 percent on the BSE.

 Source:http://www.moneycontrol.com/news/business/stocks-business/what-does-todays-oncologys-drugs-advisory-panel-meet-mean-for-biocon-clsa-explains-2324711.html

Comments

Post a Comment

Popular posts from this blog

EMA validates Incyte’s MAA for retifanlimab to treat metastatic squamous cell anal carcinoma

Incyte, global biopharmaceutical company, announced the validation of the Company’s Marketing Authorization Application (MAA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell anal carcinoma (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy. The European Medicines Agency’s (EMA) validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process. “While the incidence of SCAC is increasing in Europe, treatment options for advanced disease are limited in their effectiveness, and there are no approved options once patients have progressed on standard therapy,” said Lance Leopold, M.D., Group vice president, Immuno-Oncology Clinical Development, Incyte. “The EMA validation of the MAA for retifanlimab – which follows the recent US Food & Drug Administration acceptance of our Biologics License Application for Priority R
Read more

Merck’s Keytruda plus platinum- and fluoropyrimidine-based chemotherapy receives US FDA nod to treat certain patients with locally advanced/metastatic esophageal or GEJ carcinoma

Merck, known as MSD outside the United States and Canada, announced that the US Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapy. The approval is based on results from the phase 3 KEYNOTE-590 trial, which demonstrated significant improvements in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) for Keytruda plus fluorouracil (FU) and cisplatin versus FU and cisplatin alone, regardless of histology or PD-L1 expression status. For OS and PFS, Keytruda plus FU and cisplatin reduced the risk of death by 27% (HR=0.73 [95% CI, 0.62-0.86]; p<0.0001) and reduced the risk of disease progression or death
Read more

Tumour-targeting drug paves way for bone cancer treatment

 The treatment of osteosarcoma, the most common tumour of bone, is challenging, but a new study is offering hope to the patients with this disease. The study led by The University of  Texas MD Anderson Cancer Centre  found that a drug, known as bone metastasis-targeting peptidomimetic (BMTP-11), has potential as a new therapeutic strategy for this devastating illness. Results from the preclinical study looked at BMTP-11 alone and in combination with the chemotherapy agent gemcitabine. Although osteosarcoma is a relatively rare cancer, it is a leading disease-related cause of death in children and young adults ages 10 to 20. However, over the last 25 years, the five-year survival rate has remained unchanged, and the treatment options for these patients are few. In addition, the side effects of available treatment options often are significant and cumulative, and may cause other health problems and damage to major organs. "What's novel about this treatment is that BMTP
Read more