Press Release
Press Release
Exelixis Announces Settlement of Dispute with Genentech Regarding Companies’ Collaboration Agreement for Cobimetinib
- Companies define new revenue and cost-sharing terms for all commercial applications of cobimetinib -
- Cobimetinib’s clinical development program includes three ongoing or planned phase 3 pivotal trials -
The Amendment applies to COTELLIC®’s initial commercial
application in combination with ZELBORAF® (vemurafenib), as
well as future commercial uses of COTELLIC®, alone or in
combination. Under its terms,
“The settlement and revised revenue and commercial cost-sharing
arrangements lay the groundwork for our continued work together to
maximize cobimetinib’s potential to help patients,” said Michael M.
Morrissey, Ph.D., President and Chief Executive Officer of
Genentech has been responsible for cobimetinib’s clinical development since it opted to further develop the compound following Exelixis’ determination of a maximum tolerated dose in phase 1 clinical trials. Since then, Genentech has undertaken a clinical development program focused on evaluating cobimetinib’s potential in combination with investigational and approved therapies. This program includes three phase 3 pivotal trials: IMblaze370, an ongoing and fully enrolled study evaluating cobimetinib and atezolizumab in third-line advanced or metastatic colorectal cancer; IMspire150 TRILOGY, an ongoing trial evaluating the combination of cobimetinib, atezolizumab and vemurafenib in patients with previously untreated BRAF V600 mutation-positive metastatic or unresectable locally advanced melanoma; and IMspire170, a planned study evaluating cobimetinib plus atezolizumab in patients with previously untreated BRAF wild-type metastatic or unresectable locally advanced melanoma expected to start in the third quarter of this year.
About the Cobimetinib Development Collaboration
Under the terms of the collaboration,
Cobimetinib is now approved in multiple countries, including the U.S.,
Important: If a patient’s healthcare provider prescribes ZELBORAF® (vemurafenib), the patient should also read the Medication Guide that comes with ZELBORAF®.
COTELLIC® Indication
COTELLIC® is a prescription medicine that is used with the medicine ZELBORAF® to treat a type of skin cancer called melanoma:
- that has spread to other parts of the body or cannot be removed by surgery, and
- that has a certain type of abnormal “BRAF” gene.
A patient’s healthcare provider will perform a test to make sure that COTELLIC® is right for the patient. It is not known if COTELLIC® is safe and effective in children under 18 years of age.
Important Safety Information
Before taking COTELLIC®, patients should tell their healthcare provider about all of their medical conditions, including if they:
- have skin problems or history of skin problems, other than melanoma
- have bleeding problems, any medical conditions and/or on any medications that increase the risk of bleeding
- have heart problems
- have eye problems
- have liver problems
- have muscle problems
-
are pregnant or plan to become pregnant. COTELLIC® and
ZELBORAF® can harm an unborn baby.
- Females who are able to become pregnant should use effective birth control during treatment with COTELLIC®, and for two weeks after the final dose of COTELLIC®.
- Patients should talk to their healthcare provider about birth control methods that may be right for them.
- Patients should tell their healthcare provider right away if they become pregnant or think they are pregnant during treatment with COTELLIC® and ZELBORAF®.
- are breastfeeding or plan to breastfeed. It is not known if COTELLIC® passes into breast milk. Patients should not breastfeed during treatment with COTELLIC® and for two weeks after the final dose. Patients should talk to their healthcare provider about the best way to feed their baby during this time.
Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Certain medicines may affect the blood levels of COTELLIC®.
Patients should know the medicines they take and keep a list of them to show their healthcare provider and pharmacist when they get a new medicine.
How should patients take COTELLIC®?
- Patients should take COTELLIC® exactly as their healthcare provider tells them. Patients should not change their dose or stop taking COTELLIC® unless their healthcare provider tells them to.
- Patients should take COTELLIC® one time a day for 21 days, followed by seven days off treatment, to complete a 28-day treatment cycle.
- Patients can take COTELLIC® with or without food.
- If a patient misses a dose of COTELLIC® or vomits after taking their dose, they should take their next dose as scheduled.
What should patients avoid during treatment with COTELLIC®?
Patients should avoid sunlight during treatment with COTELLIC®. COTELLIC® can make a patient’s skin sensitive to sunlight. They may burn more easily and get severe sunburns. To help protect against sunburn:
- When a patient goes outside, they should wear clothes that protect their skin, including their head, face, hands, arms and legs.
- They should use lip balm and a broad-spectrum sunscreen with SPF 30 or higher.
What are the possible side effects of COTELLIC®?
COTELLIC® may cause serious side effects, including:
- Risk of new skin cancers. COTELLIC® may cause new skin cancers (cutaneous squamous cell carcinoma, keratoacanthoma or basal cell carcinoma).
Patients should check their skin regularly and tell their healthcare provider right away if they have any skin changes including:
- new wart
- skin sore or reddish bump that bleeds or does not heal
- change in size or color of a mole
A patient’s healthcare provider should check the patient’s skin before they start taking COTELLIC®, and every two months during treatment with COTELLIC®. A patient’s healthcare provider may continue to check the patient’s skin for six months after the patient stops taking COTELLIC®. A patient’s healthcare provider should also check for cancers that may not occur on the skin. Patients should tell their healthcare provider about any new symptoms that develop during treatment with COTELLIC®.
- Bleeding problems. COTELLIC® can cause serious bleeding problems.
Patients should call their healthcare provider and get medical attention right away if they get any signs of bleeding, including:
• red or black stools (looks like tar) |
• stomach (abdominal) pain |
|
• blood in their urine |
• unusual vaginal bleeding |
|
• headaches |
• dizziness or weakness |
|
• cough up or vomit blood |
||
- Heart problems. A patient’s healthcare provider should do tests before and during treatment to check the patient’s heart function. Patients should tell their healthcare provider if they get any of these signs and symptoms of heart problems:
• persistent coughing or wheezing |
• tiredness |
|
• shortness of breath |
• increased heart rate |
|
• swelling of their ankles and feet |
||
- Severe rash. Patients should tell their healthcare provider right away if they get any of these symptoms:
• a rash that covers a large area of their body |
• blisters |
• peeling skin |
- Eye problems. Patients should tell their healthcare provider right away if they get any of these symptoms:
• blurred vision |
• see halos |
|
• partly missing vision or loss of vision |
• any other vision changes |
|
A patient’s healthcare provider should check the patient’s eyes if the patient notices any of the symptoms above. |
- Liver problems. A patient’s healthcare provider should do blood tests to check the patient’s liver function before and during treatment. Patients should tell their healthcare provider right away if they get any of these symptoms:
• yellowing of their skin or the white of their eyes |
• feeling tired or weak |
|
• dark or brown (tea color) urine |
• loss of appetite |
|
• nausea or vomiting |
||
- Muscle problems (rhabdomyolysis). COTELLIC® can cause muscle problems that can be severe. Treatment with COTELLIC® may increase the level of an enzyme in the blood called creatine phosphokinase (CPK) and may be a sign of muscle damage. A patient’s healthcare provider should do a blood test to check the patient’s levels of CPK before and during treatment. Patients should tell their healthcare provider right away if they get any of these symptoms:
• muscle aches or pain |
• dark, reddish urine |
|
• muscle spasms and weakness |
||
- Skin sensitivity to sunlight (photosensitivity). Skin sensitivity to sunlight during treatment with COTELLIC® is common and can sometimes be severe. Patients should tell their healthcare provider if they get any of these symptoms:
• red, painful, itchy skin that is hot to touch |
• bumps or tiny papules |
|
• sun rash |
• thickened, dry, wrinkled skin |
|
• skin irritation |
||
See “What should patients avoid during treatment with COTELLIC®?” for information on protecting the skin during treatment with COTELLIC®.
The most common side effects of COTELLIC® include:
• diarrhea |
• vomiting |
|
• nausea |
• sunburn or sun sensitivity |
|
• fever |
||
A patient’s healthcare provider will take blood tests during treatment with COTELLIC®. The most common changes to blood tests include:
- increased blood levels of liver enzymes (GGT, ALT or AST)
- increased blood level of enzyme from muscle (creatine phosphokinase)
- decreased blood level of phosphate, sodium or potassium
- increased blood level of liver or bone enzyme (alkaline phosphatase)
- decreased blood level of a type of white blood cell (lymphocyte)
Patients should tell their healthcare provider if they have any side effect that bothers them or that does not go away. These are not all the possible side effects of COTELLIC®.
Patients should call their doctor for medical advice about side effects.
Patients may report side effects to
Please see Full COTELLIC®Prescribing Information and Patient Information for additional Important Safety Information at www.cotellic.com.
About
Forward-Looking Statement Disclaimer
This press release contains forward-looking statements, including,
without limitation, statements related to: the therapeutic potential and
continued development of cobimetinib; ongoing activities under the
Collaboration Agreement;
View source version on businesswire.com: http://www.businesswire.com/news/home/20170720005444/en/
Source:
Public Affairs and Investor Relations
Investors
Contact:
Exelixis, Inc.
Susan Hubbard,
650-837-8194
Executive Vice President
shubbard@exelixis.com
or
Media
Contact:
For Exelixis, Inc.
Hal Mackins,
415-994-0040
hal@torchcomllc.com