Procter & Gamble Pharmaceuticals (P&GP) announced the availability of Asacol HD (mesalamine) delayed-release tablets, which are indicated for the treatment of moderately active ulcerative colitis (UC), a form of inflammatory bowel disease. UC involves inflammation of the lining of the colon and rectum and is typically characterized by flares followed by periods of remission. Moderately active UC is characterized by tougher symptoms than mildly active UC. Asacol HD is proven to help treat these tougher flares of moderately active UC. Asacol HD was approved by the U.S. Food and Drug Administration (FDA) based on evaluations from the ASCEND studies [Assessing the Safety and Clinical Efficacy of a New Dose of 5-ASA (4.8 g/day 800 mg tablet)].

In six-week clinical studies of moderately active UC flares, Asacol HD at 4.8 g/day helped many patients reduce their UC symptoms, including number of bowel movements and rectal bleeding, for some as early as three weeks. Asacol HD decreased the number of trips to the bathroom (i.e., number of bowel movements) in approximately three out of four of patients by six weeks and decreased rectal bleeding for approximately 80 percent of patients by six weeks. Patients should discuss their experiences with Asacol HD with a physician, as their individual results may vary.

“In six-week clinical trials of moderately active UC, Asacol HD helped reduce rectal bleeding and stool frequency, without the use of steroids. These encouraging results help support Asacol HD as an effective therapy in patients with moderately active UC,” said Stephen B. Hanauer, M.D., Chief of Gastroenterology, Hepatology and Nutrition at the University of Chicago Medical Center. “Every patient’s disease is different and requires a personal approach to treatment. A course of treatment that is right for one patient may not be right for another. Patients should speak with their doctors to determine the course of therapy that is best for them.”

P&GP has been a leader in UC research and education through support of professional UC programs and research grants. P&GP is also the maker of Asacol(R) (mesalamine) 400 mg delayed-release tablets, the number one most-prescribed oral 5-aminosalicylic acid (5-ASA) therapy.* More than 20 million prescriptions have been written for Asacol since its FDA approval and U.S. launch in 1992.** Physicians have relied on Asacol as a trusted UC therapy for more than 17 years. Asacol HD is the newest addition to P&GP’s GI portfolio.

“Procter & Gamble is delighted to introduce Asacol HD to the Asacol franchise. This new addition will further help UC patients get their symptoms under control so that their lives can be more predictable,” said Dan Hecht, General Manager for P&G Pharmaceuticals, North America. “This addition to P&G’s robust portfolio of gastrointestinal therapies underscores P&G’s continued commitment to developing innovative ways to improve the lives of millions of people that struggle with GI conditions every day.”

If for any reason a patient is dissatisfied with the first course of therapy, P&GP will refund the receipted cost of the original prescription. Receipted cost includes only the amount actually paid by the patient. P&GP will not refund costs covered by third party payers, including Medicaid. Call 1-800-448-4878 for more information.

Detailed Clinical Data for Asacol HD in Moderately Active UC

The efficacy and safety of Asacol HD was evaluated in the ASCEND studies.

The primary endpoint of the ASCEND II and III studies was overall improvement at six weeks, which was determined by the Physician’s Global Assessment (PGA) which encompassed the clinical assessments of rectal bleeding, stool frequency and sigmoidoscopy findings. The Patient’s Functional Assessment (PFA) was also included in ASCEND II.

In ASCEND III, 70 percent of patients (n=273/389) achieved overall improvement with Asacol HD at 4.8 g/day as compared to 66 percent of patients (n=251/383) who took Asacol 400 mg tablets at 2.4 g/day.(1) In ASCEND II, 72 percent of patients (n=89/124) achieved overall improvement with Asacol HD at 4.8 g/day at six weeks, as compared to 59 percent of patients (n=77/130) who took Asacol 400 mg tablets at 2.4 g/day.(1,2) One Asacol HD 800 mg tablet has not been shown to be bioequivalent to two Asacol 400 mg tablets.

In addition, Asacol HD at 4.8 g/day demonstrated rapid improvement in rectal bleeding and stool frequency. At three weeks, rectal bleeding improved in 78 percent and 75 percent of the patients in the ASCEND III and ASCEND II studies, respectively. At six weeks, 84 percent of the patients taking Asacol HD at 4.8 g/day in ASCEND III and 79 percent of patients in ASCEND II experienced improvements in rectal bleeding.(1,2)

At three weeks, improvement of stool frequency was achieved by 76 percent and 64 percent of patients taking Asacol HD at 4.8 g/day in the ASCEND III and ASCEND II studies, respectively. At six weeks, the percentage of patients with improved stool frequency was 79 percent in ASCEND III and 74 percent in ASCEND II. (1,2)

About Ulcerative Colitis (UC)

UC involves inflammation of the lining of the colon and rectum. It varies in clinical severity with patients having mild, moderate or severe disease. Treatment depends on the extent and severity of disease.

UC causes flares followed by periods of remission. During a flare, in which the rectum or colon become inflamed, people experience symptoms such as diarrhea, rectal bleeding, abdominal cramping and an urgent need to go to the bathroom. Flares can vary in duration and intensity. While UC is a lifelong condition, medication may help control flares.

UC affects people of all ages, but is often diagnosed during early adulthood. The causes of this condition are unknown, but may involve heredity, infection and/or the immune system.

About Asacol and Asacol HD

Asacol is indicated for the treatment of mildly to moderately active UC and for the maintenance of remission of UC. The recommended dosage for active UC is two 400 mg tablets TID, with or without food, for a total daily dose of 2.4 g for 6 weeks. For the maintenance of remission of UC, the recommended dosage is 1.6 g/day in divided doses.

Asacol HD is indicated for the treatment of moderately active UC. The recommended dose in adults is two 800 mg tablets TID, with or without food, for a total daily dose of 4.8 g. The safety and effectiveness of Asacol HD beyond 6 weeks has not been established.

In clinical trials, Asacol and Asacol HD were generally well-tolerated. The most common adverse reactions reported in patients treated with Asacol and Asacol HD were nausea, diarrhea, abdominal pain, eructation, flatulence, exacerbation of UC, headache, rhinitis, nasopharyngitis and pain.

Asacol and Asacol HD are contraindicated in patients with hypersensitivity to salicylates. Caution should be exercised when using these products in patients with known renal dysfunction or history of renal disease. It is recommended that all patients have an evaluation of renal function prior to initiation of and periodically while on Asacol or Asacol HD therapy. Acute exacerbation of colitis symptoms can also occur. Caution should be exercised when administering Asacol or Asacol HD to patients with liver disease. Serious adverse events may occur with Asacol or Asacol HD.

About Procter & Gamble (NYSE: PG)

Three billion times a day, P&G brands touch the lives of people around the world. P&G has one of the strongest portfolios of trusted, quality, leadership brands, including Actonel(R) (risedronate sodium) tablets, Asacol(R) (mesalamine) delayed-release tablets, Asacol(R) HD (mesalamine) delayed-release tablets, Enablex(R) (darifenacin) extended release tablets, Prilosec OTC(R), Align(R), Metamucil(R), Fibersure(R), Pepto-Bismol(R), Vicks(R), PUR(R), Crest(R) and Oral-B(R). The P&G community consists of more than 135,000 employees working in over 80 countries worldwide.

References

(1) Asacol HD Package Insert (April 2009)

(2) Hanauer SB et al. Am J Gastroenterol 2005; 100: 2478-2485.

Source: Procter & Gamble Pharmaceuticals

View drug information on Prilosec.

The final analysis of the largest efficacy trial of a cervical cancer vaccine is published today in The Lancet. The study, involving 18,644 women, confirmed com/” rel=”nofollow”>GlaxoSmithKline ’s Cervarix(R) is highly effective at protecting against the two most common cervical cancer-causing human papillomavirus (HPV) types, 16 and 18. The study also showed that the vaccine provides cross-protection against HPV types 31, 33 and 45, the three most common cancer-causing virus types beyond 16 and 18.

Thomas Breuer, Head of Global Clinical R&D and Chief Medical Officer of GSK Biologicals commented: “These excellent study results confirm the efficacy offered by Cervarix(R) against HPV 16 and 18. For the first time the results show that this vaccine was effective against cervical pre-cancers associated with the five most common cancer-causing virus types. This is really good news for primary prevention of cervical cancer as it indicates the vaccine could offer women additional protection against cervical cancer beyond what had at first been anticipated.”

The study showed that in women who complied with the trial protocol procedures (87% of the total sample), the vaccine provided 92.9 percent protection against cervical pre-cancers (cervical intraepithelial neoplasia 2+ or CIN 2+) associated with HPV 16 or 18. A further analysis of the same cohort which excluded lesions not likely to be caused by HPV 16 and 18 revealed that the vaccine was 98.1 percent effective against cervical pre-cancers (CIN 2+) caused by these two types.

The study showed — for the first time for any cervical cancer vaccine — that Cervarix(R) provided significant cross-protection against pre-cancerous lesions not containing HPV types 16 and/or 18. This additional efficacy could translate into approximately 11-16 percent extra protection against cervical cancer over and above the protection afforded by efficacy against HPV 16 and 18 alone. This effect was mainly driven by protection against HPV types 31, 33 and 45.

Professor Jorma Paavonen, from the University of Helsinki, Finland — principal investigator on the study and lead author of the publication — commented: “The results show Cervarix(R) is highly effective against the most common cervical cancer-causing virus types and has the potential to substantially reduce the incidence of cervical pre-cancers, cervical cancer and the associated diagnostic and surgical procedures. The results re-affirm confidence in vaccination as a primary preventative measure against cervical cancer when used alongside screening.”

In the study, rates of serious adverse events and medically significant conditions in the group vaccinated with Cervarix(R) were similar to the control group.

About HPV 008 PATRICIA (PApilloma TRIal Cervical cancer In young Adults)

– The Phase lll multi-centre, double-blind, randomised study involved a total of 18,644 women, aged between 15 and 25 years, from 14 countries across Europe, Asia-Pacific and Latin and North America

– Study participants were randomised to receive either Cervarix(R) or a control hepatitis A vaccine and analyses were performed in the following cohorts:

– According-to-protocol cohort for efficacy (ATP-E; vaccine=8093; control=8069)

– Total vaccinated cohort (TVC; vaccine=9319, control=9325)

– Total vaccinated cohort-naive (TVC-naive; vaccine=5822; control=5819)

– ATP-E included all women who met eligibility criteria, complied with the trial protocol and received all three doses of study vaccine

– TVC included all women who received at least one vaccine dose. This group comprised a diverse population of women including those with evidence of current or previous HPV infection and with high grade smear test results. This was intended to represent general population of sexually active young women

– TVC-naive included all women who received at least one vaccine dose and who had no evidence of previous or current HPV infection, and was intended to represent young girls prior to the onset of sexual activity

– Vaccine efficacy against CIN 2+ associated with HPV 31, 33 and 45 — HPV types not in the vaccine — was 92 percent (66.0,99.2; p<0.0001), 51.9 percent (-2.9, 78.9; p=0.0332) and 100 percent (-67.8, 100, p=0.0619) respectively in the ATP-E cohort. Vaccine efficacy against CIN 2+ associated with HPV 31, 33 and 45 was 68.4 percent (34.2, 86.1; p=0.0005), 49.8 percent (4.8, 74.6; p=0.0239) and 100 percent (7.0, 100; p=0.0312) respectively in the TVC cohort

– Vaccine efficacy against CIN 2+ lesions associated with 12 non-vaccine cancer-causing HPV types not in the vaccine was 54 percent (34.0, 68.4; p<0.0001) in the ATP-E cohort. When excluding all CIN 2+ lesions associated with non-vaccine types in which HPV 16 and 18 was also detected, vaccine efficacy was 37.4 percent (7.4, 58.2; p=0.0092) in the ATP-E cohort. These two analyses suggest that the true vaccine efficacy against CIN 2+ associated with 12 non-vaccine cancer-causing HPV types lies between 37 percent and 54 percent

– The vaccine also substantially reduced the number of colposcopy referral and cervical excision procedures in both the TVC and TVC-naive cohorts

– The efficacy and safety results from the interim analysis of the HPV 008 study were previously published in The Lancet. The data reported today are from the final event driven analysis, also published in The Lancet. Further to the final analysis, additional follow-up results will be forthcoming from the end of study

About Cervarix(R)

Cervarix(R) was specifically designed with a novel adjuvant, AS04, to deliver high and sustained levels of antibodies aimed at providing long-term protection against HPV 16 and 18, the most common cervical cancer-causing HPV types. It has been shown to be generally well tolerated. The most common symptoms after vaccination included pain, redness and swelling at the injection site, fatigue, fever, aching, headache, itching, rash or gastrointestinal disturbances.

To date, Cervarix(R) has been approved in 97 countries around the world, including the 27 member states of the European Union (EU), Australia, Brazil, South Korea, Mexico and Taiwan. Licensing applications have been submitted in more than 20 additional countries including Japan and the United States. GSK also submitted the vaccine to the World Health Organization (WHO) for prequalification in September 2007.

About HPV and cervical cancer

Women are at risk of HPV infection throughout their sexually active lives. Approximately 100 types of HPV have been identified to date and, of these, approximately 15 virus types are known to cause cervical cancer. HPV types 16 and 18 are responsible for approximately 70 percent of cervical cancers globally, with types 45, 31 and 33 among the next most common cervical cancer-causing HPV strains. Persistent infection with cancer-causing HPV types can lead to abnormal Pap smears, cervical pre-cancer and cervical cancer. Cervical intraepithelial neoplasia (CIN), graded as CIN 1, 2 and 3 refers to pre-cancerous cells found on the surface of the cervix. The higher the grading number, the higher the probability the abnormal cells will become cancer cells. CIN 1, 2 and 3 refers to mild, moderate or severe cell changes respectively. CIN 2+ is the surrogate marker for cervical cancer. Worldwide, more than 500,000 women will be newly diagnosed with cervical cancer and 280,000 women will die from it each year.

HPV types 16, 18 and 45 are particularly important because these types are associated with nearly 90 percent of adenocarcinoma cases, a very aggressive type of cervical cancer more common in younger women and more difficult to detect through screening.

GlaxoSmithKline Biologicals — GSK Biologicals, GlaxoSmithKline ’s vaccines business, is one of the world’s leading vaccine companies and a leader in innovation. The company is active in the fields of vaccine research, development and production with over 30 vaccines approved for marketing and 20 more in development. Headquartered in Belgium, GSK Biologicals has 13 manufacturing sites strategically positioned around the globe. In 2008 GSK Biologicals distributed 1.1 billion doses of vaccines to 176 countries in both the developed and the developing world — an average of 3 million doses a day.

Through its accomplished and dedicated workforce, GSK Biologicals applies its expertise to discover innovative vaccines that contribute to the health and well-being of people of all generations around the world.

GlaxoSmithKline — One of the world’s leading research-based pharmaceutical and healthcare companies — is committed to improving the quality of human life by enabling people to do more, feel better and live longer

Cervarix(R) is a registered trademark of the GlaxoSmithKline group of companies.

Cautionary statement regarding forward-looking statements

Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK’s operations are described under ‘Risk Factors’ in the ‘Business Review’ in the company’ s Annual Report on Form 20-F for 2008.

Source: GlaxoSmithKline

Thallion Pharmaceuticals Inc. (TSX:TLN) announced that it has suspended patient enrollment in its Phase II trial evaluating TLN-232 as a treatment for metastatic melanoma, due to an ongoing dispute with the licensor. A binding arbitration proceeding has been initiated and Thallion will re-evaluate the status of the program based on the outcome of the adjudication.

“Based on our experience with this licensor, it is in the best long-term interests of our shareholders to suspend development of TLN-232 as opposed to investing additional resources to develop the product under recurring allegations of breach from the licensor and ensuing disputes over a termination of the license,” said Lloyd M. Segal, Chief Executive Officer of Thallion Pharmaceuticals Inc. “We believe that the assertions made against us under the license agreement are without merit. We will vigorously defend our rights in this matter, and we intend to pursue claims of our own against the licensor during the proceedings. We believe this decision represents the most responsible course of action and is especially prudent in light of today’s constrained capital environment.”

About TLN-232

TLN-232 is a novel seven amino-acid peptide with potential efficacy in multiple oncology indications and targets pyruvate kinase M2 (M2PK), a protein shown to be over-expressed in a number of different tumour types. The expression of M2PK during tumourigenesis has been shown recently to mediate the Warburg effect, a phenotype in which cancer cells utilize the glycolytic pathway to a far greater extent than do their non-malignant counterparts.

TLN-232 Phase II Trial

Thallion’s multi-centre, open label Phase II trial is targeting to enroll up to 49 metastatic melanoma patients, who have failed one prior therapy, at multiple sites in both Canada and the U.S. The trial design is comprised of a dose escalation segment followed by a dose expansion segment. The first segment consists of consecutive cohorts of at least three patients each, who will receive 0.5, 1.0, 2.0 or 3.0 mg/kg/day of TLN-232 in multiple cycles. Each cycle will consist of 21 days of treatment and seven days of rest. Once the optimal dose has been determined, the second segment of the trial will enroll and treat up to 34 additional patients at that dose until disease progression. The primary endpoint of the trial is tumour response at four months.

Source
Thallion Pharmaceuticals Inc.