Below is a look at some of the headlines for companies that made news in the healthcare sector on August 13, 2013.
It’s always good news when medical research moves a little closer to winning the war on cancer, and from the perspective of investors, it’s not such a bad outcome when it results in a five percent move in the price of the company’s stock.
That’s exactly what happened Tuesday Morning. In a press release,* Eli Lilly (NYSE: LLY)* announced that a Phase III study of Necitumumab met its primary endpoint of overall survival.
Biotech and pharma press releases can be about as easy to read as a mortgage or sadly, your last cell phone contract so here’s some plain English.
Eli Lilly has been developing a drug for the treatment of stage IV metastatic squamous non-small cell lung cancer. This is an advanced cancer that is very serious. The company designed a study, called the SQUIRE study, which set a goal—called an endpoint—of increased overall survival. If patients taking the drug survived longer than patients who didn’t, the goal or endpoint would be met.
Lilly announced that necitumumab, taken with two other cancer drugs, gemcitabine and cisplatin, increased overall survival when compared with patients who only received chemotherapy.
Related: UPDATE: Eli Lilly Posts 31% Rise In Q2 Profit, Lifts Full-Year Outlook
Also of note is the fact that this was a Phase III study. Before a drug is approved in the United States, it has to go through a series of steps. The most notable are the three phases of study. Phase I is designed to make sure the drug is safe for human use and uses healthy volunteers as test subjects.
Phase II uses patients with the condition the drug is meant to treat. The primary purpose is to see if the drug does what it’s supposed to do. If it is supposed to help control asthma, the Phase II studies have to show evidence that it’s effective for that condition.
Phase III determines if the drug is better than other treatments currently on the market. If a drug makes it to Phase III, the developer often works with the FDA to design Phase III studies. This helps the drug’s chances of gaining FDA approval.
Since the SQUIRE study announced Tuesday was a Phase III trial, that makes this announcement a big deal and that’s why the stock was soaring in the pre-market.
It still has to gain FDA approval but Eli Lilly has gone through the process enough times to know how it works. The chances of approval are high and that has the market excited.
=====================
*
Osiris Therapeutics, Inc. (NASDAQ: OSIR)*, reported its multi-center, randomized, controlled clinical trial comparing the safety and effectiveness of Grafix® to standard of care in patients with chronic diabetic foot ulcers had met the pre-specified stopping rules for overwhelming efficacy as determined by the data monitoring committee during a planned interim analysis. For the primary endpoint, 62% of patients receiving Grafix had complete wound closure compared to only 21% (p<0.0001) of patients who received conventional treatment for their wounds - a relative improvement of 191% and the largest ever reported from such a study. A total of 131 patients were enrolled with the interim analysis being conducted on the first 97 to complete the trial.
The trial also reached statistical significance in favor of Grafix on all top-line secondary endpoints, demonstrating faster wound closure and a reduction in the number of treatments needed to achieve wound closure. In the crossover phase of the trial, patients whose wounds failed to close after 12 weeks of standard of care had an 80% closure rate when switched to Grafix. Importantly, patients randomized to receive standard of care were 74% more likely to experience an adverse event than those receiving Grafix (p=0.008). As a result, the blinded phase of the trial is being discontinued immediately and all patients randomized to the control arm will be offered treatment with Grafix.
*Also Tuesday:*
*Ambit Biosciences (NASDAQ: AMBI)*, a biopharmaceutical company focused on discovery and development of drugs targeting unmet needs in oncology, autoimmune and inflammatory disease, today announced results for the second quarter and six months ended June 30, 2013.
*Athersys, Inc. (Nasdaq:ATHX)* today announced its financial results for the three months ended June 30, 2013.
*BIOLASE, Inc. (NASDAQ: BIOL)*, the world's leading manufacturer and distributor of dental lasers, and a pioneer in laser surgery in other medical specialties, announced that, as disclosed in the Form 10-Q filed on August 9, 2013, Comerica Bank ("Comerica") agreed to waive BIOLASE's® non-compliance with a condition in the Loan and Security Agreement, dated May 24, 2012, by and between BIOLASE and Comerica, as amended (the "Loan Agreement").
*Boston Scientific Corporation (NYSE: BSX)* completed a public offering of $1.05 billion aggregate principal amount of its senior notes under the company's shelf registration statement.
*Burcon NutraScience Corporation (TSX:BU) (Nasdaq:BUR)*, a leader in functional, renewable plant proteins, reported results for the fiscal first quarter ended June 30, 2013.
*Cancer Genetics, Inc. (Nasdaq:CGIX)*, a diagnostics company focused on developing genomic-based, oncology tests and services, today announced the pricing of its public offering of 1,500,000 shares of its common stock at a price to the public of $10.00 per share.
*CollabRx, Inc. (Nasdaq:CLRX)* today announced financial results for the first quarter of fiscal year 2014, which ended June 30, 2013.
*Competitive Technologies, Inc. (OTCQX:CTTC)* announced today its financial results for the six months ended June 30, 2013.
Michigan-based health and wellness company* Health Enhancement Products (OTCBB: HEPI)* has notified shareholders that the Company's annual shareholder meeting will be held on August 21, 2013 at the Westin Hotel directly adjacent to the McNamara terminal of Detroit Metro Airport (DTW) beginning 10:00AM EDT and concluding at noon.
*Generex Biotechnology Corporation (OTCBB: GNBT)* today announced that Dr. Eric von Hofe, Ph.D., President of its wholly-owned subsidiary, Antigen Express, Inc. (www.antigenExpress.com), will be making a presentation at the Emerging Cancer Immunotherapies and Vaccines conference that is being held as part of the 2013 Immunotherapies Congress in BostonAugust 13-14.
*Heat Biologics, Inc. (NASDAQ: HTBX)*, a clinical stage biopharmaceutical company focused on the development of novel cancer immunotherapies, today announced the partial exercise of the over-allotment option granted to the underwriters to purchase an additional 100,000 shares of its common stock, at a price to the public of $10.00 per share, in connection with the Company's recently announced underwritten public offering of 2,500,000 shares of common stock, bringing total gross proceeds from the offering to $26,000,000, before underwriting discounts and commissions and other offering expenses payable by the Company.
*
Health Insurance Innovations, Inc. (Nasdaq:HIIQ)*, a leading developer and administrator of affordable, cloud-based individual health insurance plans and ancillary products, today reported financial and operating results for the second quarter and six months ended June 30, 2013.
*Intrexon Corporation (NYSE: XON)* today announced the closing of its previously announced initial public offering of common stock.
*IsoRay Inc. (NYSE MKT: ISR) (NYSE Amex: ISR)* (www.IsoRay.com), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications, today announced it will host a booth at the 55th Annual Meeting of the American Society for Radiation Oncology (ASTRO).
*Merus Labs International Inc. (TSX:MSL) (NASDAQ:MSLI)* is pleased to announce today its financial results for the third quarter of fiscal 2013.
*Medigus, Ltd. (TASE: MDGS)*, a leading medical device company dedicated to the development of innovative endoscopy-based surgical procedures and technologies, announced today that its Board of Directors has approved the appointment of Mr. Christopher (Chris) Rowland as chief executive officer of the company.
*MRI Interventions, Inc. (OTCQB:MRIC)*, a commercial stage medical device company focused on creating innovative platforms for performing the next generation of minimally invasive surgical procedures in the brain and heart, announced today its financial results for the quarter ended June 30, 2013.
*
MYOS Corporation (OTCBB: MYOS)*, a company focused on the discovery, development and commercialization of therapeutic and dietary products that improve human muscle health and performance ("MYOS" or the "Company"), today announced its financial results for the second quarter ended June 30, 2013 and its recent key operational highlights representing expanded research and manufacturing accomplishments.
*Myriad Genetics, Inc. (Nasdaq:MYGN) *today announced financial results for its fiscal fourth quarter and full fiscal year ended June 30, 2013.
*Ocera Therapeutics, Inc. (Nasdaq:OCRX)*, a clinical stage biopharmaceutical company focused on the development and commercialization of proprietary compounds to treat acute and chronic orphan liver diseases, today announced its financial results and business update for the second quarter ended June 30, 2013.
*Pressure BioSciences, Inc. (OTCQB: PBIO)* today announced that the Company will host a teleconference to discuss its Second Quarter 2013 financial results and to provide a business update.
*PURE Bioscience (OTCQB: PURE)*, creator of the patented silver dihydrogen citrate (SDC) antimicrobial, today announced a leadership reorganization beginning with the return of Dave Pfanzelter as chairman of the board of directors.
*Response Biomedical Corp. (TSX:RBM) (OTCBB:RPBIF) *today reported financial results for the quarter and six months ended June 30, 2013.
*Stevia First Corp. (OTCQB: STVF)*, an early-stage agribusiness based in California's Central Valley and focused on the industrial scale production of stevia, is building support and acceptance for stevia by broadening its involvement within the USDA's IR-4 Program and helping provide domestic stevia growers with tools for long-term, reliable stevia leaf production.
*TearLab Corporation (Nasdaq:TEAR) (TSX:TLB) *today reported its consolidated financial results for the second quarter ended June 30, 2013.
*
Yew Bio-Pharm Group, Inc. (OTCBB: YEWB)*, a major grower and seller of yew trees, yew raw materials used in the manufacture of traditional Chinese medicine and products made from yew timber in China, today announced financial results for the second quarter ended June 30, 2013. Reported by Proactive Investors 3 hours ago.
It’s always good news when medical research moves a little closer to winning the war on cancer, and from the perspective of investors, it’s not such a bad outcome when it results in a five percent move in the price of the company’s stock.
That’s exactly what happened Tuesday Morning. In a press release,* Eli Lilly (NYSE: LLY)* announced that a Phase III study of Necitumumab met its primary endpoint of overall survival.
Biotech and pharma press releases can be about as easy to read as a mortgage or sadly, your last cell phone contract so here’s some plain English.
Eli Lilly has been developing a drug for the treatment of stage IV metastatic squamous non-small cell lung cancer. This is an advanced cancer that is very serious. The company designed a study, called the SQUIRE study, which set a goal—called an endpoint—of increased overall survival. If patients taking the drug survived longer than patients who didn’t, the goal or endpoint would be met.
Lilly announced that necitumumab, taken with two other cancer drugs, gemcitabine and cisplatin, increased overall survival when compared with patients who only received chemotherapy.
Related: UPDATE: Eli Lilly Posts 31% Rise In Q2 Profit, Lifts Full-Year Outlook
Also of note is the fact that this was a Phase III study. Before a drug is approved in the United States, it has to go through a series of steps. The most notable are the three phases of study. Phase I is designed to make sure the drug is safe for human use and uses healthy volunteers as test subjects.
Phase II uses patients with the condition the drug is meant to treat. The primary purpose is to see if the drug does what it’s supposed to do. If it is supposed to help control asthma, the Phase II studies have to show evidence that it’s effective for that condition.
Phase III determines if the drug is better than other treatments currently on the market. If a drug makes it to Phase III, the developer often works with the FDA to design Phase III studies. This helps the drug’s chances of gaining FDA approval.
Since the SQUIRE study announced Tuesday was a Phase III trial, that makes this announcement a big deal and that’s why the stock was soaring in the pre-market.
It still has to gain FDA approval but Eli Lilly has gone through the process enough times to know how it works. The chances of approval are high and that has the market excited.
=====================
*
Osiris Therapeutics, Inc. (NASDAQ: OSIR)*, reported its multi-center, randomized, controlled clinical trial comparing the safety and effectiveness of Grafix® to standard of care in patients with chronic diabetic foot ulcers had met the pre-specified stopping rules for overwhelming efficacy as determined by the data monitoring committee during a planned interim analysis. For the primary endpoint, 62% of patients receiving Grafix had complete wound closure compared to only 21% (p<0.0001) of patients who received conventional treatment for their wounds - a relative improvement of 191% and the largest ever reported from such a study. A total of 131 patients were enrolled with the interim analysis being conducted on the first 97 to complete the trial.
The trial also reached statistical significance in favor of Grafix on all top-line secondary endpoints, demonstrating faster wound closure and a reduction in the number of treatments needed to achieve wound closure. In the crossover phase of the trial, patients whose wounds failed to close after 12 weeks of standard of care had an 80% closure rate when switched to Grafix. Importantly, patients randomized to receive standard of care were 74% more likely to experience an adverse event than those receiving Grafix (p=0.008). As a result, the blinded phase of the trial is being discontinued immediately and all patients randomized to the control arm will be offered treatment with Grafix.
*Also Tuesday:*
*Ambit Biosciences (NASDAQ: AMBI)*, a biopharmaceutical company focused on discovery and development of drugs targeting unmet needs in oncology, autoimmune and inflammatory disease, today announced results for the second quarter and six months ended June 30, 2013.
*Athersys, Inc. (Nasdaq:ATHX)* today announced its financial results for the three months ended June 30, 2013.
*BIOLASE, Inc. (NASDAQ: BIOL)*, the world's leading manufacturer and distributor of dental lasers, and a pioneer in laser surgery in other medical specialties, announced that, as disclosed in the Form 10-Q filed on August 9, 2013, Comerica Bank ("Comerica") agreed to waive BIOLASE's® non-compliance with a condition in the Loan and Security Agreement, dated May 24, 2012, by and between BIOLASE and Comerica, as amended (the "Loan Agreement").
*Boston Scientific Corporation (NYSE: BSX)* completed a public offering of $1.05 billion aggregate principal amount of its senior notes under the company's shelf registration statement.
*Burcon NutraScience Corporation (TSX:BU) (Nasdaq:BUR)*, a leader in functional, renewable plant proteins, reported results for the fiscal first quarter ended June 30, 2013.
*Cancer Genetics, Inc. (Nasdaq:CGIX)*, a diagnostics company focused on developing genomic-based, oncology tests and services, today announced the pricing of its public offering of 1,500,000 shares of its common stock at a price to the public of $10.00 per share.
*CollabRx, Inc. (Nasdaq:CLRX)* today announced financial results for the first quarter of fiscal year 2014, which ended June 30, 2013.
*Competitive Technologies, Inc. (OTCQX:CTTC)* announced today its financial results for the six months ended June 30, 2013.
Michigan-based health and wellness company* Health Enhancement Products (OTCBB: HEPI)* has notified shareholders that the Company's annual shareholder meeting will be held on August 21, 2013 at the Westin Hotel directly adjacent to the McNamara terminal of Detroit Metro Airport (DTW) beginning 10:00AM EDT and concluding at noon.
*Generex Biotechnology Corporation (OTCBB: GNBT)* today announced that Dr. Eric von Hofe, Ph.D., President of its wholly-owned subsidiary, Antigen Express, Inc. (www.antigenExpress.com), will be making a presentation at the Emerging Cancer Immunotherapies and Vaccines conference that is being held as part of the 2013 Immunotherapies Congress in BostonAugust 13-14.
*Heat Biologics, Inc. (NASDAQ: HTBX)*, a clinical stage biopharmaceutical company focused on the development of novel cancer immunotherapies, today announced the partial exercise of the over-allotment option granted to the underwriters to purchase an additional 100,000 shares of its common stock, at a price to the public of $10.00 per share, in connection with the Company's recently announced underwritten public offering of 2,500,000 shares of common stock, bringing total gross proceeds from the offering to $26,000,000, before underwriting discounts and commissions and other offering expenses payable by the Company.
*
Health Insurance Innovations, Inc. (Nasdaq:HIIQ)*, a leading developer and administrator of affordable, cloud-based individual health insurance plans and ancillary products, today reported financial and operating results for the second quarter and six months ended June 30, 2013.
*Intrexon Corporation (NYSE: XON)* today announced the closing of its previously announced initial public offering of common stock.
*IsoRay Inc. (NYSE MKT: ISR) (NYSE Amex: ISR)* (www.IsoRay.com), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications, today announced it will host a booth at the 55th Annual Meeting of the American Society for Radiation Oncology (ASTRO).
*Merus Labs International Inc. (TSX:MSL) (NASDAQ:MSLI)* is pleased to announce today its financial results for the third quarter of fiscal 2013.
*Medigus, Ltd. (TASE: MDGS)*, a leading medical device company dedicated to the development of innovative endoscopy-based surgical procedures and technologies, announced today that its Board of Directors has approved the appointment of Mr. Christopher (Chris) Rowland as chief executive officer of the company.
*MRI Interventions, Inc. (OTCQB:MRIC)*, a commercial stage medical device company focused on creating innovative platforms for performing the next generation of minimally invasive surgical procedures in the brain and heart, announced today its financial results for the quarter ended June 30, 2013.
*
MYOS Corporation (OTCBB: MYOS)*, a company focused on the discovery, development and commercialization of therapeutic and dietary products that improve human muscle health and performance ("MYOS" or the "Company"), today announced its financial results for the second quarter ended June 30, 2013 and its recent key operational highlights representing expanded research and manufacturing accomplishments.
*Myriad Genetics, Inc. (Nasdaq:MYGN) *today announced financial results for its fiscal fourth quarter and full fiscal year ended June 30, 2013.
*Ocera Therapeutics, Inc. (Nasdaq:OCRX)*, a clinical stage biopharmaceutical company focused on the development and commercialization of proprietary compounds to treat acute and chronic orphan liver diseases, today announced its financial results and business update for the second quarter ended June 30, 2013.
*Pressure BioSciences, Inc. (OTCQB: PBIO)* today announced that the Company will host a teleconference to discuss its Second Quarter 2013 financial results and to provide a business update.
*PURE Bioscience (OTCQB: PURE)*, creator of the patented silver dihydrogen citrate (SDC) antimicrobial, today announced a leadership reorganization beginning with the return of Dave Pfanzelter as chairman of the board of directors.
*Response Biomedical Corp. (TSX:RBM) (OTCBB:RPBIF) *today reported financial results for the quarter and six months ended June 30, 2013.
*Stevia First Corp. (OTCQB: STVF)*, an early-stage agribusiness based in California's Central Valley and focused on the industrial scale production of stevia, is building support and acceptance for stevia by broadening its involvement within the USDA's IR-4 Program and helping provide domestic stevia growers with tools for long-term, reliable stevia leaf production.
*TearLab Corporation (Nasdaq:TEAR) (TSX:TLB) *today reported its consolidated financial results for the second quarter ended June 30, 2013.
*
Yew Bio-Pharm Group, Inc. (OTCBB: YEWB)*, a major grower and seller of yew trees, yew raw materials used in the manufacture of traditional Chinese medicine and products made from yew timber in China, today announced financial results for the second quarter ended June 30, 2013. Reported by Proactive Investors 3 hours ago.