Roche (SIX: RO, ROG; OTCQX: RHHBY) /Genetech’s Herceptin:
Q: Investorideas.com staff:
When was the licensing agreement put in place with Genentech and Roche for Herceptin®?
A: Nina Goworek, Investor Relations Officer for Roche
Genentech and Roche signed a licensing agreement giving Roche exclusive marketing rights for Herceptin outside of the US in July 1998
Q: Investorideas.com staff:
What other cancers are targeted with Herceptin® other than HER2-positive breast cancer and what FDA approvals are in place?
A: Nina Goworek, Investor Relations Officer for Roche
In the US:
September 1998 - Herceptin is approved for 1st-line Her2 positive metastatic breast cancer in combination with chemotherapy (paclitaxel) and also approved as a medicine to be used alone for women who had received prior chemotherapy (second- and third-line treatment),
November 2006 - Herceptin is approved for adjuvant or early stage HER2 positive breast cancer when given with chemotherapy (doxorubicin, cyclophosphamide and paclitaxel), a combination called AC-TH
January 2008 - approved as a stand-alone medicine following anthracycline-based chemotherapy
May 2008 - Herceptin and chemotherapy (docetaxel and carboplatin), known as TCH, was approved; Another AC-TH combination, comprised of Herceptin, doxorubicin, cyclophosphamide and docetaxel, was also approved
October 2010 - Herceptin is approved in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease (1st-line)
Q: Investorideas.com staff:
The Company recently announced in June the FDA approved for Perjeta in combination with Herceptin- how does this combination improve results?
A; Nina Goworek, Investor Relations Officer for Roche
The addition of Perjeta in combination with Herceptin plus docetaxel (chemo) showed an increase of progression free survival (PFS) from a median of 12.4 months to 18.5 months - an increase of 6.1months. Statistically significant overall survival top-line results were announced with the data to be presented at an upcoming medical meeting.
Q: Investorideas.com staff:
What is the current number of women with HER2-positive breast cancer have been treated with Herceptin?
A; Nina Goworek, Investor Relations Officer for Roche
As of January 2012, there were roughly 440,000 patients treated with Herceptin in the US for all indications and more that 1.2 million people have been treated with Herceptin globally.
Sunshine Biopharma Inc. (OTCBB: SBFM) and Adva-27a
Q: Investorideas.com
Can you give us a brief history of the development of Adva-27a?
A: Mr. Camille Sebaaly, CFO of Sunshine Biopharma Inc
Adva-27a is a small molecule which we designed and synthesized de novo. The patents covering Adva-27a and derivatives in the United States and Europe have issued recently. Various patents in other places around the world are still pending. Adva-27a was designed to specifically target multidrug resistant (or aggressive) types of cancer.
Q: Investorideas.com staff
From your recent press releases you now have data on both lung and breast cancer results for Adva-27a, potentially doubling the market potential. Can you give investors a brief summary of the results to date?
A: Mr. Camille Sebaaly, CFO of Sunshine Biopharma Inc.
There are different types of transporter proteins which when overexpressed make cancer cells resistant to drugs. Different multidrug resistant cancer types may overexpress different transporter proteins. Our data to date have shown that Adva-27a can overcome two multidrug resistance proteins: MDR1 and MRP1 as present in the breast cancer cells and the lung cancer cells we tested. Lung and breast cancer are the two most frequently encountered cancers in humans.
Q: Investorideas.com staff
How do your collaborations withthe State University of New York at Binghamton and McGill University’s Jewish General Hospital in Montreal ( Canada) help you take Adva-27a to clinical trials?
A: Mr. Camille Sebaaly, CFO of Sunshine Biopharma Inc
We are delighted for the help, dedication and contribution of these two of the finest institutions in the world. They have and continue to be of great help to us in our efforts to put Adva-27a through the drug development stages. We anticipate that our first clinical trial will be done at the Jewish General Hospital on breast cancer volunteers.
Q: Investorideas.com staff
For investors looking at a small biotech company like yours, taking on the big pharma companies, how do you address the massive financial and corporate undertaking of bringing Adva-27a to market?
A: Mr. Camille Sebaaly, CFO of Sunshine Biopharma Inc
It is indeed very costly to bring a drug to market. We have been fortunate in our financing efforts to date and we hope to be able to continue to access the private and public markets for funding on an as needed basis to continue the development of our flagship Adva-27a and bring it to market for cancer sufferers around the world.
Q: Investorideas.com staff
Do you have any third party projections for the market potential ofAdva-27a?
A: Mr. Camille Sebaaly, CFO of Sunshine Biopharma Inc
We have not commissioned any one to do projections of market potential of our Adva-27a. However, we do know that important cancer drugs generally reach annual sales of about $1 billion within 1 to 2 years of FDA approval. We believe Adva-27a will have a similar sales profile.
About Sunshine Biopharma Inc. (OTCBB: SBFM):
Sunshine Biopharma is a pharmaceutical company focused on the research, development and commercialization of drugs for the treatment of various forms of cancer. The Company’s lead compound, Adva-27a targets aggressive forms of cancer.
www.sunshinebiopharma.com
About Roche (SIX: RO, ROG; OTCQX: RHHBY):
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2011, Roche had over 80,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 42.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan.
www.roche.com
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Learn more about Sunshine Biopharma Inc. (OTCBB:SBFM): ProfileDisclaimer/ Disclosure: The Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising. Disclosure: A third party on behalf of SBFM compensates Investorideas.com for news release publishing and distribution : one hundred thousand 144 shares for three months starting June 26th
BC Residents and Investor Disclaimer: Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
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