Targeting Aggressive Forms of Cancer: Sunshine Bio (OTCBB: SBFM) and Roche (OTCBB: RHHBY)

Northern, WI 7/9/12 (StreetBeat) -- Investorideas.com, an investor research portal specializing in sector research including biotech and pharma stocks, issues a report on biotech companies targeting aggressive forms of cancer; Roche’s (OTCBB: RHHBY) Herceptin® cancer drug and Sunshine Biopharma Inc. (OTCBB: SBFM) with its lead compound, Adva-27a.

Roche is the largest biotech company in the world and Sunshine Biopharma is a small microcap biopharma company. The two genes associated with aggressive forms of cancer are Her2 and Top2; Roche is targeting Her2-Positive patients and Sunshine Biopharma is targeting multidrug resistant Top2, which has no current effective drugs in the market for patients.

Mr. Camille Sebaaly, CFO of Sunshine Biopharma Inc. (OTCBB: SBFM) recently noted in an interview with Investorideas.com “Herceptin® is an excellent drug and is very effective in treating Her2-Positive breast cancer patients. However, only about 25% of the breast cancer patients are Her2-Positive. For the remaining 75%, Herceptin® does not work. This is where our Adva-27a comes in.”

Sunshine Biopharma reported on July 11, 2011 that Adva-27a had shown 16-fold more effectiveness against MCF-7/MDR Multidrug Resistant Breast Cancer and announced on June 26th results that Adva-27a is significantly more effective at killing Multidrug Resistant Small-Cell Lung Cancer cells than Etoposide, the current commonly used drug for this type of cancer.

Adva-27a was designed and synthesized de novo in 2006. Patents covering Adva-27a and derivatives have recently issued in the United States and Europe and are pending in other countries around the world. Sunshine Biopharma has announced collaborations with the State University of New York at Binghamton and McGill University’s Jewish General Hospital in Montreal (Canada) focused on the development of Adva-27a through clinical trials.

Herceptin® was developed originally by Genentech, starting with research that dated back to the 1970’s and Roche later signed a licensing agreement in 1998 for exclusive marketing rights for Herceptin outside of the United States. A few months later Herceptin received FDA approval for use in women with breast cancer that overexpresses the HER2 protein. Herceptin® was the first therapeutic antibody targeted to a specific (HER2) cancer-related molecular marker to receive FDA approval. Roche purchased Genentech in March 2009 for approximately $46.8 billion.

The most recent development on Herceptin® was June this year when Roche announced the FDA had approved Perjeta® (pertuzumab) in combination with Herceptin® and docetaxel chemotherapy for the treatment of people with Her2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

Herceptin® sales were over $5 billion in 2010 but Herceptin® begins to lose patent protection in world markets in 2014.



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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Junior Biotech Roche (OTCBB: RHHBY) to Start Human Trials in Quest for New Breast Cancer Treatments

Atlanata, GA 5/10/12 (StreetBeat) – The battle against breast cancer looks to be getting a few more weapons in its arsenal in the future. Swiss drug giant Roche took a shot in the arm in November of 2011 when the Food and Drug Administration revoked their Genentech unit’s Avastin as an indication for breast cancer, but Roche (OTCBB: RHHBY) is providing some promising research with their new pertuzumab drug in recent months. The experimental antibody is being used as an addition to Roche’s blockbuster breast cancer drug, Herceptin, and chemotherapy. The latest data shows that the new concoction can add six months to the lives of HER2-positive breast cancer patients. Herceptin, also known as tratuzumab, had 2010 global sales of $6.8 billion.

On the same front, other drug makers are providing optimistic results across the full range of research. Novartis's (NYSE:NVS) is developing Afinitor (everolimus) - which is already approved for other cancers - showed that treatment with it delays disease progression by four months among metastatic patients. Earlier on in development, Sunshine Biopharma(OTCBB:SBFM) is wrapping-up laboratories studies on Adva-27, a small molecule that targets and inhibits Top2, the second enzyme (HER-2 is the other) associated with aggressive forms of breast cancer. Also taking a step in the right direction helping to re-shape the treatments for breast cancer patients is Seattle, Washington-based TapImmune Inc. (OTCBB:TPIV).

A vaccine technology company, TapImmune received allowance from the FDA last year and recently got Institutional Review Board approval for a Phase I clinical trial to be hosted at the Mayo Clinic in Rochester, Minnesota. Today, TapImmune told investors that the company-sponsored trial is set to begin to test its novel set of HER2/neu Class II antigens in breast cancer patients who finished standard Herceptin-based therapy and are at a high risk of disease recurrence.

As a result of what the company called an “overwhelming response” from patients expressing interest to be in the trial, TapImmune expects the trial to be fully subscribed. The primary endpoints of the study will be safety and immunogenicity - the ability of a particular substance, such as an antigen or epitope, to provoke an immune response in the body of a human or animal. Representing a significant milestone, this is the first clinical trial to be run to test TapImmune’s HER-2/neu vaccine program.

There are four companies with four different root targets for the treatment of breast cancer with each striving to generate revenue while providing a solution to a disease that took the life of approximately 40,000 women in 2011, with about 300,000 new cases diagnosed. Proper due diligence on each is, as always, encouraged.

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Vivus (Nasdaq: VVUS), Arena (Nasdaq: ARNA) Unlikely to Be Affected by FDA Obesity Panel

Chicago, IL 3/30/12 (StreetBeat) – Arena Pharmaceuticals Inc. (Nasdaq: ARNA) and Vivus Inc. (Nasdaq: VVUS), competing to win U.S. regulatory approval for weight-loss treatments, probably won’t be affected by an advisory panel’s recommendation for heart-risk studies, a Food and Drug Administration spokeswoman said.

The panel voted 17-6 yesterday in Silver Spring, Maryland, to recommend that companies developing weight-loss therapies should conduct clinical trials to assess heart danger or review pre-approval human trial data on heart attacks and strokes. The panel’s goal was to help the agency update guidelines for bringing obesity treatments to market, Erica Jefferson, a spokeswoman for the FDA, said in an e-mail today.

“It’s unlikely that the discussions over the past couple days will impact any existing applications,” Jefferson said.

Vivus, Arena and a third California-based company, Orexigen Therapeutics Inc. (Nasdaq: OREX), are racing to bring the first weight-loss pill to market in 13 years. The fen-phen appetite-suppression drug combination was pulled from pharmacies 15 years ago when it was linked to heart-valve abnormalities.

Vivus rose 7.5 percent to $22.88 at 9:43 a.m. New York time. Arena increased 1.6 percent to $3.09 and Orexigen fell 3.5 percent to $4.38.

The FDA is set to make a decision on Mountain View, California-based Vivus’s drug Qnexa by April 17. San Diego-based Arena’s treatment lorcaserin faces an advisory panel May 10, with the agency expected to make a decision by June 27.

Orexigen agreed in September with the FDA to conduct a two- year study of heart risks for the drug Contrave. The La Jolla, California-based company is a partner with Takeda Pharmaceutical Co. (4502), based in Osaka, Japan.

Two-Tiered Studies

Panel members agreed studies should be two tiered: pre- and post-approval. Companies should rule out a certain degree of risk during pre-approval and further prove the drugs don’t cause excessive heart harm after the medicines are on the market, advisers said during discussion. The FDA isn’t required to follow the panel’s guidance.

The panel voted Feb. 22 that Qnexa’s benefits outweigh its risks. Sanjay Kaul, a professor in the David Geffen School of Medicine at UCLA Cedar Sinai Medical Center and a panel member, said the treatment works the best to help patients lose weight, giving it a good chance of the FDA requiring post-approval studies on heart risk instead of additional ones before.

The last obesity drug the FDA approved was Roche Holding AG (Pinksheets: RHHBY)’s Xenical in 1999.Abbott Laboratories (NYSE: ABT) withdrew its obesity treatment Meridia in 2010 after a post-market trial revealed a 16 percent increase in risk of heart attack or stroke in those taking the product over those using a placebo and little difference in weight loss.

Arena is studying its compound lorcaserin to assess cancer risks. The company is in a partnership with Tokyo’s Eisai Co. (4523)

The FDA previously has rejected all three drugs, asking for more data on safety risks, including the likelihood of birth defects associated with Qnexa.

More than 78 million U.S. adults are obese, according to the Centers for Disease Control and Prevention in Atlanta. Obesity raises the risks of diabetes, heart attacks and stroke, and costs the U.S. economy an estimated $147 billion a year in medical expenses and lost productivity, according to the CDC.

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ImmunoGen (Nasdaq: IMGN) Rises After Drug Delays Cancer Worsening in Study

Chicago, IL 3/30/12 (StreetBeat) – ImmunoGen Inc. (Nasdaq: IMGN) rose the most in almost a year after partner Roche Holding AG (Pinksheets: RHHBY) said a breast cancer drug delayed the disease worsening in a patient study.

ImmunoGen climbed as much as 16 percent to $15.87, the biggest intraday gain since April 11, 2011. It was up 12 percent to $15.31 at 9:37 a.m. New York time. The Waltham, Massachusetts-based company rose 60 percent in the year before today.

Patients who received the medicine, T-DM1, lived “significantly” longer without their disease progressing compared with those who received a combination of GlaxoSmithKline Plc (Nasdaq: GSK)’s Tykerb and Roche’s Xeloda, Basel, Switzerland-based Roche said in a statement today. Roche is developing T-DM1 with technology it licensed from ImmunoGen.

The trial hasn’t been running long enough to show whether the drug also extended women’s lives, Roche said. Roche said it plans to apply for regulatory approval for T-DM1, also known as trastuzumab emtansine, in Europe and the U.S. this year.

“This lends further credibility to Roche’s ability to protect and increase its breast cancer revenues despite the likely appearance of biosimilar Herceptin,” analysts led by Mark Purcell atBarclays Capital wrote in a note today.

Biosimilars are lower-cost versions of complex drugs made from living organisms.

The treatment combines Roche’s Herceptin, which brought in $6 billion in 2011, according to data compiled by Bloomberg, with an older chemotherapy.

T-DM1 is a so-called “armed antibody” that combines Herceptin with DM1, which is derived from an old chemotherapy medicine called maytansine. That drug was found to be too toxic for patients in clinical trials two decades ago. ImmunoGen’s technology enabled chemists to fuse DM1 to Herceptin in such a way that it isn’t activated until Herceptin shepherds it directly to the cancer cell.

The U.S. Food and Drug Administration rejected a request in 2010 to accelerate the regulatory process.

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Where is Buffett Looking

Investment Underground ran a screen to filter picks Warren Buffett would like: sustainable business advantages producing significant free cash flows, and healthy returns on equity in excess of 10%.

They also screened for market caps larger than $10 billion in order to “move the needle,” meaning, Warren could acquire enough shares to make the investment worthwhile given Berkshire's (BRK.A) size. Investment Underground provided 12 names that are consistent with Berkshire's investment philosophy. One is a current holding (BDX) and one is a former holding (WU).

Of the 12 picks, 8 are healthcare related. Considering Buffett's ever-increasing stake in Johnson and Johnson (JNJ), any of the names in this screen are fair game for an entry by the conglomerate.

Abbott Laboratories (ABT): This pharmaceutical powerhouse yields 3.61% and has a history of raising its dividend. The company's portfolio of patent protected drugs, along its excellent nutritional and diagnostic groups and its history of strategic acquisitions have dug ABT a wide economic moat, a criterion Buffett often looks for in his investments.

Becton, Dickinson & Company (BDX): Another healthcare giant, Becton has carved out significant market share in the medical tool market. As of 9/30/2010, Buffett owns .81% of shares outstanding. And like Abbott, Becton has a long history of raising its dividend, which is among the highest in the industry (1.9%). But unlike ABT, Becton doesn't have a sea of patent protected drugs to shield it from competition and many of its products have been commoditized, creating a narrow moat for the company.

Cisco Systems (CSCO): Buffett has brought tech executives to Berkshire's board, including Susan Decker. As well, Bill Gates, Walter Scott, Jr. and lawyer Ronald Olsen are not strangers to old and new technologies. Cisco is the dominant player in data networking produces tons of cash-flow and will continue to as this growth story keeps growing.

Covidien (COV): This producer of all things healthcare is raising its quarterly dividend 11% to $.20 a share. This is the second consecutive year COV has upped its yield.

Exelon (EXC): With the largest nuclear fleet of any U.S. utility, Exelon's 11 nuclear plants generate 17% of U.S. nuclear power and constitute 80% of Exelon's generation output. This is a low risk, wide moat operation with room to run. The company has traded upwards of $85 a piece. At the time of writing, EXC trades at $40 a share and yields 5.3%.

France Telecom (FTE): FT spits off about 8 billion Euros a year in free cash flow and should continue to for the next 5 years, allowing the company to pay off its debt load of around 34 billion errors net of cash and continue to increase its dividend which yields 5.7%. FTE as well has a solid history of increasing its dividend, though it did cut it in half during 2009 due to slowed wireless and broadband growth.

Medtronic (MDT): This Company dominates the medical equipment space, holding market leading positions in heart devices, insulin pumps, and spinal products. Medtronic trades on a TTM price to earnings ratio of 10.9. Compare that to an industry P/E of 16.5, throw in a 2.5% yield, a wide economic moat, and a recent increase in Goldman's price target to $36 a share, and you have a stock that fits Berkshire's investment philosophy.

Novartis (NVS): The Swiss-based pharmaceutical maker has a healthy balance sheet and a free cash flow yield of ~ 8%. The company's healthy intellectual property portfolio has created a wide moat for itself, which will likely remain as long as Novartis can continue to fuel its late stage pipeline and keep making targeted acquisitions.

Roche Holdings (RHHBY.PK): The other big boy of the Swiss pharma giants, Roche yields 3.2% and has a solid drug portfolio and pipeline, due to the company's acquisition of Genentech in 2009.

St. Jude Medical (STJ): One of Medtronic's biggest rivals, St. Jude's maintains an economic moat thanks to its diversified product offering and its key position in the $550 million dollar vascular closure market. What's more, 45% of STJ's sales come from abroad. The company could easily trade in the $45-$50 per share range as healthcare spending recovers along with the broader economy.

Western Union (WU): Buffett has owned WU in the past. And for good reason. The company is the largest money transfer company in the world. The size of the company has proved to be an advantage as many smaller rivals have been driven out of business because of regulatory requirements they couldn't keep pace with.

Zimmer Holdings (ZMH): Shares of ZMH appear cheap considering the company's market share and demographic trends on the horizon. The company leads the hip and knee implant industry, an industry which should see solid growth as the baby boomers keep getting older.