Quadramet® has been thoroughly studied in clinical trials.  There are at least 123 published and unpublished studies, trials and review articles that evaluate aspects of the therapy and can be found in literature searches. (Please contact Superna for bibliography.)  Additionally, numerous consensus treatment guidelines include Quadramet®.  Among those are the American Society of Therapeutic Radiation Oncology (ASTRO), Cancer Care Ontario practice guidelines, the Society of Nuclear Medicine and the Alberta Practice Guidelines for Palliative Radiation Therapy.

Multiple studies published in peer-reviewed journals, showed that Quadramet provided a statistically significant reduction in pain and narcotics use.

Indication Statement:

Quadramet is indicated for relief of pain in patients with confirmed osteoblastic metastatic bone lesions that enhance on bone scan.

Safety Information:

Because of unknown potential for additive side effects on bone marrow, Quadramet should not be given concurrently with chemotherapy or external beam radiation therapy unless clinical benefits outweigh the risks.  Commonly observed adverse events with Quadramet include marrow toxicity (47% of patients in clinical trials.) Myelosupression may increase the risk of infectious or hemorrhagic adverse events.  Non-hemotologic events that occurred were pain flare (7%), diarrhoea (6%) and spinal chord compression (6.5%.)  Patients taking Quadramet should have blood counts monitored for 8 weeks or until recovery of adequate bone marrow.

Precautions:

Quadramet should not be used in patients that have a known hypersenstitivty to EDTMP or similar phosphonate compounds; women of childbearing age should have a negative pregnancy test before administration of Quadramet.  Patients who receive Quadramet should be advised that for several hours following administration, radioactivity will be present in excreted urine.  To help protect themselves and others in the environment, precautions need to be taken for 12 hours following administration.

About Superna Life Sciences Inc.

Superna Life Sciences is a Canadian pharmaceutical company focused on providing unique medications for under served therapeutic categories related to cancer care or rare diseases.  Superna currently has two approved products, Caphosol and Quadramet.  Additionally, Superna has recently completed a submission to Health Canada for a third product, which has the potential to be launched in the third quarter of 2013.

For information about Quadramet, please contact us at 1-877-469-1254.

For information about Caphosol, please visit our website www.caphosol.ca.

In comparison with the control group, the Caphosol group had a statistically significant lower measure of WHO oral toxicity; duration of oral mucositis (3.2 v 7.1 days, p=0.02); analgesic use (1.1 vs 3.4 days, p=0.047); need for TPN (0 vs 6 patients, p=0.02 and days of TPN 0 days vs 1.9 days, p=0.009.)

The author concludes that the Caphosol group had significantly less oral toxicity, lower peak mouth pain, shorter duration of mucositis, and less need for expensive supportive care products like TPN.

COMMENTARY:

This study replicates the results favouring Caphosol over placebo in another prospective, randomized, controlled trial published by Papas et al in Bone Marrow Transplantation (2003) 31, 705-712, “A prospective, randomized trial for the prevention of mucositis in patients undergoing hematopietic stem cell transplantation.” In both trials the duration of OM was cut by more than half. Patients used significantly less narcotics with median days of morphine use was 0.0 in the Caphosol group vs 3.0 in the control group, p=0.00015.

With two randomized, controlled trials one has to ask the following question: is there a reason not to offer Caphosol to patients receiving high-dose chemotherapy with stem cell support? Caphosol has two controlled trials showing benefit. One of the most commonly used products, Magic Mouthwash, has none showing benefit. The risk benefit ratio is important to consider. Caphosol has an outstanding safety profile. No Caphosol-related SAEs were observed in the randomized, controlled trials. Caphosol has a very good safety profile, similar to toothpaste for example. (Please see prescribing information at www.caphosol.ca.)

Additionally, Caphosol has shown in two trials it has a dramatic impact on reducing the amount of narcotics needed and the duration of narcotics used. Few would argue against measures that help patients avoid narcotics.

Our view is a low-cost, safe, proven product that reduces the need for expensive supportive care should be used in all transplant units.

All patients receiving an autologous stem cell transplantation after BEAM conditioning between 12/2006 and 6/2011 were included. Patients receiving palifermin were excluded. Calcium-phosphate rinse (Caphosol) was used 4 times a day from the first day of conditioning until the end of neutropenia. Two sequential cohorts were analysed, cohort A before, cohort B after the introduction of Caphosol as prophylaxis for oral mucositis.

Statistically significant reductions in grade 3 and grade 4 oral mucositis (mouth sores from cancer treatment)using the WHO scale were seen in the Caphosol-treated cohort (p = 0.02) Additionally, patients in the Caphosol cohort benefitted by needing significantly less total parenteral nutrition, TPN, p = 0.011.

Caphosol is a cost-effective, safe, oral rinse used in patients who have received high-dose chemotherapy, radiation, or both in numerous studies. Reducing the cost of TPN is a consideration when deciding to use Caphosol. This study is one of several to show that patients on Caphosol require less nutritional support than patients in the comparator arms which may have included chlorhexidine, or magic mouthwash.

For more information on cancer-related mouth sores, visit www.mouthsmadegood.com or to learn more about Caphosol visit www.caphosol.ca.

In comparison with the control group, the Caphosol group had a statistically significant lower measure of WHO oral toxicity; duration of oral mucositis (3.2 v 7.1 days, p=0.02); analgesic use (1.1 vs 3.4 days, p=0.047); need for TPN (0 vs 6 patients, p=0.02 and days of TPN 0 days vs 1.9 days, p=0.009.)

The author concludes that the Caphosol group had significantly less oral toxicity, lower peak mouth pain, shorter duration of mucositis, and less need for expensive supportive care products like TPN.

COMMENTARY:

This study replicates the results favouring Caphosol over placebo in another prospective, randomized, controlled trial published by Papas et al inBone Marrow Transplantation(2003) 31, 705-712, “A prospective, randomized trial for the prevention of mucositis in patients undergoing hematopietic stem cell transplantation.” In both trials the duration of OM was cut by more than half. Patients used significantly less narcotics with median days of morphine use was 0.0 in the Caphosol group vs 3.0 in the control group, p=0.00015.

With two randomized, controlled trials one has to ask the following question: is there a reason not to offer Caphosol to patients receiving high-dose chemotherapy with stem cell support when other alternatives have no data supporting their use? Caphosol has two controlled trials showing benefit. One of the most commonly used products, Magic Mouthwash, has no data showing benefit. The risk benefit ratio is important to consider too. Caphosol has an outstanding safety profile. No Caphosol-related SAEs were observed in the randomized, controlled trials. Caphosol has a very good safety profile, similar to toothpaste for example. (Please see prescribing information at www.caphosol.ca.)

Additionally, Caphosol has shown in two trials it has a dramatic impact on reducing the amount of narcotics needed and the duration of narcotics used. Few would argue against measures that help patients avoid narcotics.

Our view is a low-cost, safe, proven product that reduces the need for expensive supportive care should be used in all transplant units.

Superna Life Sciences, a Vancouver-based specialty pharma company, focused on the Canadian cancer care market, received its Drug Establishment Licence (DEL) from Health Canada. With the DEL, Superna announces its intention to launch Quadramet in Q1 of 2012. Quadramet (Sm-153 lexidronam) is a radiopharmaceutical product that is indicated for patients with severe bone pain due to tumours that have spread to the bones.

The DEL clears the way for Superna to market Quadramet. It offers an alternative for patients who have multiple tumours that have spread to the bone from the primary site. Quadramet only works on one type of metastatic tumour categorized as osteoblastic. Prostate cancer and breast cancer are the most common types that spread to the bones AND form osteoblastic lesions. Quadramet offers an alternative to patients who can no longer have these tumours in their bones treated by external beam radiation. These patients often face an ever-increasing need morphine to control their pain. Clinical studies with Quadramet show that patients reduce the need for morphine. For more information about the appropriate use and the side effects of Quadramet, visit www.quadrametinfo.com.

Superna is currently launching its first product, Caphosol, for the prevention and treatment of oral mucositis in patients who have severe mouth sores due to chemotherapy, radiation therapy or both. There is a high unmet need for Caphosol in patients undergoing marrow or stem cell transplant; in patients who receive multiple cycles of 5-FU for colorectal cancer; in patients receiving multiple cycles of docetaxel, taxotere, and anthracyclines for breast cancer; and patients who receive radiation to the mouth, neck and pharynx. For information about mouths sores go to www.mouthsmadegood.com. For information specific to Caphosol visit www.caphosol.ca.

CAPHOSOL provides a solution to a problem with a high unmet need in a small group of cancer patients. Until CAPHOSOL was approved, patients were treated reactively with mouth-numbing elixirs containing analgesics or narcotics. The introduction of CAPHOSOL is a paradigm shift, offering doctors and nurses the opportunity to prevent and treat mouth sores in high risk patients.

Superna has two products in its portfolio: CAPHOSOL and QUADRAMET(Sm-153 lexidronam.) Please see QUADRAMET prescribing information for treatment of metastatic bone lesions and its associated safety information. Superna Life Sciences is focused on the acquisition and commercialization of medically important pharmaceutical products in Canada for the treatment of cancer and supportive care products used to treat the side effects of the cancer or its treatments.

For more information, please contact Superna Life Sciences at 1-877-465-1254 or visit our web site www.supernapharma.com

FOR IMMEDIATE RELEASE

QUADRAMET (Samarium-153 Lexidronam Injection) Exclusive Distribution Agreement

Superna Life Sciences, Inc. of Vancouver has completed a distribution agreement with EUSA Pharma (Langhorne, PA, USA) for the exclusive rights to market and sell Quadramet ^c (Samarium-153 Lexidronam Injection) in Canada.

Quadramet is a calcium mimetic with a radioactive payload. It was recently approved by Health Canada, receiving its Notice of Compliance in 4Q of 2010. Quadramet is indicated for the relief of pain in patients with confirmed osteoblastic lesions that enhance on radionuclide bone scan.

Quadramet works by preferentially distributing to sites in the bone where the primary tumour has spread. Tumour cells in the bones are more active than normal bone cells and thus absorb the majority of the Quadramet. The Quadramet damages or kills the offending tumour cells, significantly reducing excruciating bone pain.

In two, randomized, placebo-controlled trials with a total of 580 patients who had painful metastatic bone lesions, Quadramet showed a significant and persistent benefit in terms of pain versus the placebo group. Patients’ weekly pain scores were lowered and significant reductions in morphine usage were seen over the duration of the study. More recent studies have been published in the Journal of Clinical Oncology demonstrating utility in a consolidation regimen with docetaxel in prostate cancer patients. Quadramet has been studied extensively in prostate cancer and breast cancer. It has also been studied in multiple myeloma and lung cancer.

Superna is initiating a program at Centres of Excellence in Canada that will allow qualifying patients to try Quadramet free of charge this Fall.

Precautionary statement: QUADRAMET causes bone marrow suppression. Before QUADRAMET is administered, consideration should be given to the patient’s current clinical and hematologic status and bone marrow response history to treatment with myelotoxic agents. Because of the unknown potential for additive effects on bone marrow, QUADRAMET should not be given concurrently with chemotherapy or external beam radiation therapy unless the clinical benefits outweigh the risks.

About Superna Life Sciences, Inc.

Superna is a privately-held pharma company based in Vancouver, BC. Superna focuses on the sale of niche, cancer-care products in the Canadian market. Superna will be launching two products, Caphosol and Quadramet in 2011. You can learn more by going to www.supernpharma.com,www.quadramet-us.com or www.caphosol.ca.

About EUSA Pharma

EUSA Pharma is a rapidly growing transatlantic specialty pharmaceutical company focused on oncology, oncology supportive care and critical care products. The company has an established commercial infrastructure in the U.S., a pan-European presence and a wider distribution network in numerous additional territories. EUSA currently has a total of 10 specialist hospital products, which are sold in over 80 countries globally*. These include Erwinase/Erwinaze and Kidrolase for the treatment of acute lymphoblastic leukemia, Caphosol for the treatment of oral mucositis, a common and debilitating side-effect of radiation therapy and high dose chemotherapy, Collatamp G, a surgical implant impregnated with the antibiotic gentamicin, ProstaScint for imaging the extent and spread of prostate cancer and Quadramet for the treatment of pain in patients whose cancer has spread to the bones. The company also has several products in late-stage development.

* Not all are approved for use in the U.S.

Contact

1-604-630-1100 or 1-877-469-1254

www.supernapharma.com

Last year, more than one million Americans underwent radiation and chemotherapy for treatment of their cancers, according to the National Institutes of Health.

Of those, approximately 400,000 suffered from oral mucositis — a painful condition that is linked to the effects of radiation therapy, and which manifests itself as inflammation and ulceration of the upper gastrointestinal tract. Oftentimes, patients’ symptoms are so severe as to require heavy doses of pain medication and dietary restrictions. Even then, some patients may still need intravenous nutrition and full hospitalization.

Such was not the case, however, for 25-year-old Andy Sorice, a marketing professional who came to Temple University Hospital for the treatment of mucoepidermoid carcinoma of the parotid gland, a rare head-and-neck cancer.

After having a tumor in his neck surgically removed in July of 2010, Sorice was referred to Curtis Miyamoto, MD, Temple’s Chief of Radiation Oncology, for follow-up radiation treatment. During their introductory meeting, Miyamoto explained to his new patient the likelihood that he would develop oral mucositis as a byproduct of the scheduled radiation treatments, but then also informed him of his eligibility to enroll in a clinical trial designed to study the effectiveness of a special mouthwash, called Caphosol, that could prevent or reduce the incidence of mucositis.

As a former college football player, Sorice is used to responding quickly on the field and off — so it wasn’t surprising that he signed-up immediately for the study. The results, he said, speak for themselves. “I didn’t experience a single symptom of mucositis, and all I had to do was swish it around in my mouth a couple times a day.”

Complete resolution of symptoms

The young Manayunk resident’s results mirrored those of others who have benefited from the prophylactic use of Caphosol— which is a supersaturated rinse that works by coating the upper GI tissues from the ravages of radiation.

In addition, equally impressive results have also been seen in patients whose severe symptoms of oral mucositis (including acute pain, loss of blood and tissue, and an inability to eat) have required their hospitalization. In many of those patients, the use of Caphosol resulted in the near or total remission of their symptoms — which meant no more pain medication and a return to eating nutritious meals. Such remarkable results have reinforced Miyamoto’s view that Caphosol can be a highly effective treatment for radiation patients who experience the painful challenges of oral mucositis.

An advocate

Other studies of Caphosol, manufactured by EUSA Pharma, have shown similar results. Indeed, a recent retrospective study, led by Miyamoto, found that the use of Caphosol before radiation therapy eliminated entirely the need for hospitalization in a small group of head-and-neck cancer patients; and its use significantly reduced the severity of symptoms and the need for intravenous feedings.

As a result of those and other studies, Miyamoto (who has no financial interest in EUSA Pharma) has become a strong advocate for the use of Caphosol in appropriate patients who require radiation therapy as part of their treatment plan for cancer. He also supports and speaks to the need for having the product recognized by the Centers for Medicare and Medicaid Services (CMS) as a reimbursable cancer treatment. “Providing reimbursement for Caphosol is the right thing to do, considering the clinical and quality-of-life benefits it provides,” said Miyamoto. “For many patients, Caphosol can mean reduced hospitalizations, reduced complications and costs, and a better patient experience.”

Purpose: The purpose of this study was to evaluate Caphosol for the prevention and treatment of mucositis (mouth sores) compared to the previous standard treatment—chlorhexidine rinse.

Materials/methods: 60 patients were assessed. Thirty patients who received standard treatment with chlorhexidine mouth rinse were compared to 30 patients who received Caphosol mouth rinse. All patients in the Caphosol arm were instructed to rinse with Caphosol four times daily from the start of radiotherapy until radiation therapy was completed. Patients were monitored through weekly clinic assessment. Patients were assessed for grade of oral musositis (OM); weight change; performance status; and pain.

Results: The analysis showed statistically significant superiority in OM grade and in analgesic steps for Caphosol versus chlorhexidine. The median for Caphosol was superior in weeks 4,5, 6 and 7 between the two mouthwashes. The p value for week 4 was p=0.0, week 5 p=0.001, week 6 p=0.001, and week 7 p=0.003. Results for intake of food and liquids was significantly greater from weeks 2-7 in the Caphosol group. This shows that patients using Caphosol can eat and drink more during treatment.

Conclusions: These positive results are encouraging with statistical significance in the reduction of overall grade of OM and the reduced use of analgesic pain mediations. These results are consistent with previously published studies in head and neck cancer and other solid tumours like breast cancer and colorectal cancer.

About Head & Neck tumours: According to Canadian Cancer Society/National Cancer Institute of Canada statistics, approximately 3,200 Canadians are diagnosed with oral cancers every year. An additional 1,150 are diagnosed with cancer in the larynx. All of the patients receiving chemotherapy and/or radiation therapy will be at risk of severe oral musocisits. The current standard is to wait for patients to have severe mouth sores, then treat with something to numb the pain combined with something to prevent super infection. To learn more visit www.mouthsmadegood.com.

About Caphosol: Caphosol is a supersaturated calcium phosphate rinse administered by the patient at least four times per day. Caphosol is a significant change in the approach to managing mouth sores from cancer treatments by offering Canadian patients prevention. Caphosol has demonstrated the ability to prevent severe oral mucositis and reduce it’s duration in patients who use the mouth rinse at least four times per day starting on the day they receive their first chemotherapy or radiation treatment. Caphosol contains 75mg of sodium per dose, so patients who are restricted to low sodium diets should consult their physician prior to starting Caphosol treatment. To learn more visit www.caphosol.ca.

About Superna Life Sciences, Inc.: Superna is a privately-held, pharmaceutical company based in Vancouver, BC. Superna’s focus is to commercialize products for cancer patients to treat rare conditions or to treat the complications that arise from cancer therapies used to treat rarer tumour types. These patients often have few treatment alternatives. Superna’s mission is to provide solutions for these patients. To learn more visit www.supernapharma.com.