IDEAYA and Pfizer Expand Clinical Trial Collaboration and Supply Agreement to Evaluate Clinical Combination of IDE196 and Crizotinib in Solid Tumors Harboring GNAQ or GNA11 Mutations

IDEAYA Biosciences, Inc. (NASDAQ: IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics to treat cancer, today announced that it has expanded its clinical trial collaboration and supply agreement with Pfizer Inc. (NYSE: PFE) for an IDEAYA sponsored clinical combination study of IDE196, a Protein Kinase C (PKC) inhibitor, and crizotinib, a cMET inhibitor to which Pfizer has exclusive worldwide rights. The study will evaluate IDE196 and crizotinib combination therapy in patients with solid tumors having GNAQ or GNA11 mutations (GNAQ11), including metastatic uveal melanoma (MUM), skin melanoma, lung cancer and colorectal cancer.

Evaluating MUM patient clinical samples, IDEAYA identified cMET expression or activation as a potentially valuable biomarker that may guide IDE196 clinical treatment in this indication. IDEAYA also demonstrated preclinical synergy in MUM with the combination of IDE196 and crizotinib, which further supports the potential biomarker on cMET expression.

"We are excited to expand our agreement with Pfizer to evaluate the clinical combination of IDE196 and crizotinib in MUM and other solid tumors with GNAQ or GNA11 mutations," said Mick O'Quigley, Vice President, Head of Development Operations, IDEAYA Biosciences. "Through our translational research we have identified cMET expression as a potential biomarker, and we are excited to explore this rational combination between IDE196 and crizotinib clinically," said Mark Lackner , Ph.D., Senior Vice President, Head of Biology and Translational Sciences.

IDEAYA's clinical development plan in MUM for IDE196 is based on combination therapies, including with binimetinib, a MEK inhibitor, and crizotinib, a cMET inhibitor, enabled through our clinical trial collaboration and drug supply agreement with Pfizer. The company announced First-Patient-In (FPI) for the IDE196 and binimetinib clinical combination in June 2020 and is targeting FPI for the crizotinib clinical trial combination in late 2020 to early 2021. IDEAYA is also evaluating IDE196 as monotherapy in an ongoing GNAQ/11 non-MUM basket trial in additional solid tumor types, including in skin melanoma, where the company announced Phase 2 expansion.

IDEAYA and Pfizer have established a Joint Development Committee (JDC), and there will be joint decision making and data sharing of the clinical trial results between the parties. IDEAYA will sponsor the study and Pfizer will provide the crizotinib drug supply. If there is clinical data from the collaboration studies that could be used to obtain regulatory approvals or label changes, IDEAYA and Pfizer will enter into good faith negotiations to determine a regulatory submission strategy.

About IDEAYA Biosciences
IDEAYA is an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics. IDEAYA's approach integrates capabilities in identifying and validating translational biomarkers with small molecule drug discovery to select patient populations most likely to benefit from the targeted therapies IDEAYA is developing. IDEAYA is applying these capabilities across multiple classes of precision medicine, including direct targeting of oncogenic pathways and synthetic lethality – which represents an emerging class of precision medicine targets.

Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to (i) the clinical potential of crizotinib in combination with IDE196, including whether the combination will enhance the response rate, and the depth and durability of clinical benefit and (ii) the timing of initiation of the combination clinical trial of IDE196 plus crizotinib in late 2021 to early 2022. Such forward-looking statements involve substantial risks and uncertainties that could cause IDEAYA's preclinical and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including IDEAYA's programs' early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, IDEAYA's ability to successfully establish, protect and defend its intellectual property and other matters that could affect the sufficiency of existing cash to fund operations. IDEAYA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, see IDEAYA's recent Quarterly Report on Form 10-Q filed on August 12, 2020 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

View original content to download multimedia: https://www.prnewswire.com/news-releases/ideaya-and-pfizer-expand-clinical-trial-collaboration-and-supply-agreement-to-evaluate-clinical-combination-of-ide196-and-crizotinib-in-solid-tumors-harboring-gnaq-or-gna11-mutations-301137168.html

SOURCE IDEAYA Biosciences, Inc.

News Provided by PR Newswire via QuoteMedia

Pfizer PFE Pharmaceutical Investing

Arvinas Enters into a Transaction with Novartis, including a Global License Agreement for the Development and Commercialization of PROTAC® Androgen Receptor Protein Degrader ARV-766 for the Treatment of Prostate Cancer

Arvinas to receive a $150 million upfront payment for the license of ARV-766 and the sale of Arvinas' preclinical AR-V7 program, with the potential under the License Agreement for up to $1.01 billion in development, regulatory, and commercial milestones, as well as tiered royalties –

– Novartis to be responsible for worldwide clinical development and commercialization of ARV-766 –

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

New Novartis data show early addition of twice-yearly* Leqvio® following maximally tolerated statin therapy significantly reduces LDL-C in ASCVD patients in real-world setting

V- INITIATE trial demonstrates that early initiation with Leqvio, prior to guideline-recommended ezetimibe, for ASCVD patients unable to achieve LDL-C goal on statin therapy alone led to significant LDL-C reduction vs. clinician-determined usual care (60% vs. 7% respectively) ¹
A significantly greater proportion of the ASCVD patients receiving Leqvio achieved guideline-recommended LDL-C goal vs. the usual care arm while maintaining adherence to statin treatment ¹
Results from usual care arm reinforce the urgent need for more aggressive LDL-C lowering in ASCVD patients, 92% of whom did not reach their LDL-C goal with statins alone ¹
The Leqvio safety profile was consistent with the Phase III clinical studies and long-term open-label extension trials for up to 6 years of treatment ^1-4

Novartis today announced new data demonstrating the early addition of twice-yearly* Leqvio ® (inclisiran) to maximally tolerated statin therapy, prior to guideline-recommended ezetimibe, in a real-world setting significantly reduced low-density lipoprotein cholesterol (LDL-C) in patients with atherosclerotic cardiovascular disease (ASCVD), including those with a history of an ASCVD-related event, who could not reach their goal on statin therapy alone 1 . The late-breaking data were presented at the 2024 American College of Cardiology's Annual Scientific Session & Expo and simultaneously published in the Journal of the American College of Cardiology .

"V-INITIATE evaluated a solution to the important challenge seen in clinical practice of too many patients with ASCVD not achieving guideline-recommended LDL-C goal on statins alone and effective non-statin therapies being markedly underutilized," said Michael Koren , M.D., Medical Director and CEO of Jacksonville Center for Clinical Research, and the primary investigator of the study. "Given the urgent need to more aggressively manage LDL-C, the results from V-INITIATE show that when added earlier in the treatment continuum, the structured use of effective non-statin therapies like Leqvio can significantly reduce LDL-C for ASCVD patients who are struggling to reach or maintain their LDL-C goal."

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Jamieson Wellness Publishes Inaugural Sustainability Impact Report

From values to action, the Company details progress towards its sustainability commitments in its "Inspiring Better Lives Every Day: 2023 Sustainability Impact Report"

Jamieson Wellness Inc. ("Jamieson Wellness" or the "Company") (TSX: JWEL) today announces the release of its "Inspiring Better Lives Every Day: 2023 Sustainability Impact Report". The comprehensive report underscores the Company's commitment to creating a sustainable future while aligning with its core values of Respect, Excellence, Accountability, and Agility. The Company's new purpose, "Inspiring Better Lives Every Day," serves as its guiding light as it navigates the path toward positive impact.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Jamieson Wellness Inc. Reports Strong Fourth Quarter and Full Year 2023 Results

Profitable revenue growth of 23.5% in 2023 demonstrates successful execution of global strategy;
Canadian consumer consumption reaches record levels in Q4

Jamieson Wellness Inc. ("Jamieson Wellness" or the "Company") (TSX: JWEL) today reported financial results for its fourth quarter and full year results for the period ended December 31, 2023. All amounts are expressed in Canadian dollars. Certain metrics, including those expressed on an adjusted basis, are non-IFRS and other financial measures. See "Non-IFRS and Other Financial Measures" below.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Novartis Media Relations E-mail: media.relations@novartis.com

North America
Michael Meo	+1 862 274 5414
Marlena Abdinoor	+1 617 335 9525

Novartis Investor Relations E-mail: investor.relations@novartis.com

North America
Sloan Simpson	+1 862 345 4440
Jonathan Graham	+1 201 602 9921
Parag Mahanti	+1 973 876 4912

Jamieson Wellness Inc. Selected Consolidated Financial Information In thousands of Canadian dollars, except share and per share amounts

	Three months ended				Twelve months ended
	December 31				December 31
	2023		2022		2023		2022

Revenue	220,365		192,775		676,172		547,369
Cost of sales	141,338		121,586		442,613		349,031
Gross profit	79,027		71,189		233,559		198,338

Gross profit margin	35.9	%	36.9	%	34.5	%	36.2	%

Selling, general and administrative expenses	42,300		32,768		140,304		110,239
Acquisition related adjustments	(7,863	)	-		(7,863	)	-
Share-based compensation	1,534		1,317		5,868		4,910
Earnings from operations	43,056		37,104		95,250		83,189

Operating margin	19.5	%	19.2	%	14.1	%	15.2	%

Foreign exchange loss	1,676		978		1,962		269
Interest expense and other financing costs	4,885		5,757		22,784		12,417
Accretion on preferred shares	1,965		-		4,833		-
Earnings before income taxes	34,530		30,369		65,671		70,503
Provision for income taxes	10,530		8,278		19,631		17,695
Net earnings	24,000		22,091		46,040		52,808

Net earnings attributable to:
Shareholders	24,407		22,091		47,882		52,808
Non-controlling interests	(407	)	-		(1,842	)	-
	24,000		22,091		46,040		52,808
Adjusted net earnings	28,615		26,759		66,084		65,149

EBITDA	46,516		41,201		113,611		100,168
Adjusted EBITDA	50,628		48,871		138,063		123,761

Adjusted EBITDA margin	23.0	%	25.4	%	20.4	%	22.6	%

Weighted average number of shares
Basic	42,062,117		41,683,753		41,960,516		40,998,065
Diluted	42,766,299		42,817,044		42,650,501		42,116,350

Earnings per share attributable to common shareholders:
Basic, earnings per share	0.57		0.53		1.10		1.29
Diluted, earnings per share	0.56		0.52		1.08		1.25
Adjusted diluted, earnings per share	0.67		0.62		1.55		1.55

Jamieson Wellness Inc. Consolidated Statements of Financial Position In thousands of Canadian dollars

	December 31, 2023	December 31, 2022
Assets
Current assets
Cash	36,863	26,240
Accounts receivable	164,499	160,798
Inventories	182,456	154,488
Derivatives	3,707	6,580
Prepaid expenses and other current assets	5,335	4,298
	392,860	352,404
Non-current assets
Property, plant and equipment	106,903	111,709
Goodwill	274,411	272,916
Intangible assets	366,521	367,205
Deferred income tax	2,879	3,029
Total assets	1,143,574	1,107,263

Liabilities
Current liabilities
Accounts payable and accrued liabilities	135,520	142,566
Income taxes payable	2,263	7,387
Current portion of other long-term liabilities	7,546	4,852
	145,329	154,805
Long-term liabilities
Long-term debt	325,000	400,000
Post-retirement benefits	1,078	929
Deferred income tax	60,532	58,007
Redeemable preferred shares	89,409	-
Other long-term liabilities	41,031	61,931
Total liabilities	662,379	675,672

Equity
Share capital	312,593	307,200
Warrants	14,705	-
Contributed surplus	19,089	17,115
Retained earnings	80,654	85,483
Accumulated other comprehensive income	11,892	21,793
Total shareholders' equity	438,933	431,591
Non-controlling interests	42,262	-
Total equity	481,195	431,591
Total liabilities and equity	1,143,574	1,107,263

Jamieson Wellness Inc. Segment Information In thousands of Canadian dollars, except as otherwise noted

Jamieson Brands

		Three months ended December 31
		2023		2022		$ Change		% Change

	Revenue	181,007		155,996		25,011		16.0	%

	Gross profit	73,082		65,345		7,737		11.8	%
	Amortization of fair value adjustments	2,621		793		1,828		230.5	%
	Normalized gross profit	75,703		66,138		9,565		14.5	%

	Gross profit margin	40.4	%	41.9	%	-		(1.5	%)
	Normalized gross profit margin	41.8	%	42.4	%	-		(0.6	%)

	Share-based compensation ⁽¹⁾	1,534		1,317		217		16.5	%

	Selling, general and administrative expenses	40,751		31,165		9,586		30.8	%
	Acquisition and divestiture related costs ⁽²⁾	(2,846	)	(3,165	)	319		10.1	%
	IT system implementation ⁽³⁾	(3,274	)	(1,417	)	(1,857	)	(131.1	%)
	Normalized selling, general and administrative expenses	34,631		26,583		8,048		30.3	%

	Earnings from operations	38,660		32,863		5,797		17.6	%
	Acquisition and divestiture related costs ⁽²⁾	2,846		3,165		(319	)	(10.1	%)
	IT system implementation ⁽³⁾	3,274		1,417		1,857		131.1	%
	Amortization of fair value adjustments ⁽⁴⁾	2,621		793		1,828		230.5	%
	Acquisition related purchase consideration and post-closing adjustments ⁽⁵⁾	(7,863	)	-		(7,863	)	(100.0	%)
	Normalized earnings from operations	39,538		38,238		1,300		3.4	%

	Operating margin	21.4	%	21.1	%	-		0.3	%
	Normalized operating margin	21.8	%	24.5	%	-		(2.7	%)

	Adjusted EBITDA	45,404		43,832		1,572		3.6	%
	Adjusted EBITDA margin	25.1	%	28.1	%	-		(3.0	%)


Strategic Partners

		Three months ended December 31
		2023		2022		$ Change		% Change

	Revenue	39,358		36,779		2,579		7.0	%

	Gross profit	5,945		5,844		101		1.7	%
	Gross profit margin	15.1	%	15.9	%	-		(0.8	%)

	Selling, general and administrative expenses	1,549		1,603		(54	)	(3.4	%)
	Other	(24	)	-		(24	)	-
	Normalized selling, general and administrative expenses	1,525		1,603		(78	)	(4.9	%)

	Earnings from operations	4,396		4,241		155		3.7	%
	Other	24		-		24		-
	Normalized earnings from operations	4,420		4,241		179		4.2	%

	Operating margin	11.2	%	11.5	%	-		(0.3	%)
	Normalized operating margin	11.2	%	11.5	%	-		(0.3	%)

	Adjusted EBITDA	5,224		5,039		185		3.7	%
	Adjusted EBITDA margin	13.3	%	13.7	%	-		(0.4	%)

Jamieson Wellness Inc. Segment Information (continued) In thousands of Canadian dollars, except as otherwise noted

Jamieson Brands

		Twelve months ended December 31
		2023		2022		$ Change		% Change

	Revenue	551,171		439,147		112,024		25.5	%

	Gross profit	214,293		184,039		30,254		16.4	%
	Amortization of fair value adjustments ⁽⁴⁾	8,440		793		7,647		964.3	%
	Normalized gross profit	222,733		184,832		37,901		20.5	%

	Gross profit margin	38.9	%	41.9	%	-		(3.0	%)
	Normalized gross profit margin	40.4	%	42.1	%	-		(1.7	%)

	Share-based compensation ⁽¹⁾	5,868		4,910		958		19.5	%

	Selling, general and administrative expenses	133,951		103,996		29,955		28.8	%
	Acquisition and divestiture related costs ⁽²⁾	(8,385	)	(12,919	)	4,534		35.1	%
	IT system implementation ⁽³⁾	(7,743	)	(4,527	)	(3,216	)	(71.0	%)
	Other	179		(127	)	306		240.9	%
	Normalized selling, general and administrative expenses	118,002		86,423		31,579		36.5	%

	Earnings from operations	82,337		75,133		7,204		9.6	%
	Acquisition and divestiture related costs ⁽²⁾	8,385		12,919		(4,534	)	(35.1	%)
	IT system implementation ⁽³⁾	7,743		4,527		3,216		71.0	%
	Amortization of fair value adjustments ⁽⁴⁾	8,440		793		7,647		964.3	%
	Acquisition related purchase consideration and post-closing adjustments ⁽⁵⁾	(7,863	)	-		(7,863	)	(100.0	%)
	Other	(179	)	127		(306	)	(240.9	%)
	Normalized earnings from operations	98,863		93,499		5,364		5.7	%

	Operating margin	14.9	%	17.1	%	-		(2.2	%)
	Normalized operating margin	17.9	%	21.3	%	-		(3.4	%)

	Adjusted EBITDA	121,836		113,088		8,748		7.7	%
	Adjusted EBITDA margin	22.1	%	25.8	%	-		(3.7	%)


Strategic Partners

		Twelve months ended December 31
		2023		2022		$ Change		% Change

	Revenue	125,001		108,222		16,779		15.5	%

	Gross profit	19,266		14,299		4,967		34.7	%
	Gross profit margin	15.4	%	13.2	%	-		2.2	%

	Selling, general and administrative expenses	6,353		6,243		110		1.8	%
	Other	(96	)	(48	)	(48	)	(100.0	%)
	Normalized selling, general and administrative expenses	6,257		6,195		62		1.0	%

	Earnings from operations	12,913		8,056		4,857		60.3	%
	Other	96		48		48		100.0	%
	Normalized earnings from operations	13,009		8,104		4,905		60.5	%

	Operating margin	10.3	%	7.4	%	-		2.9	%
	Normalized operating margin	10.4	%	7.5	%	-		2.9	%

	Adjusted EBITDA	16,227		10,673		5,554		52.0	%
	Adjusted EBITDA margin	13.0	%	9.9	%	-		3.1	%

Reconciliation of Non-IFRS Financial Measures In thousands of Canadian dollars

	Three months ended				Twelve months ended
	December 31				December 31
	2023		2022		2023		2022


Net earnings:	24,000		22,091		46,040		52,808
Add:
Provision for income taxes	10,530		8,278		19,631		17,695
Interest expense and other financing costs	4,885		5,757		22,784		12,417
Accretion on preferred shares	1,965		-		4,833		-
Depreciation of property, plant, and equipment	3,589		3,579		14,410		12,153
Amortization of intangible assets	1,547		1,496		5,913		5,095

Earnings before interest, taxes, depreciation, and amortization (EBITDA)	46,516		41,201		113,611		100,168
Share-based compensation ⁽¹⁾	1,534		1,317		5,868		4,910
Foreign exchange loss	1,676		978		1,962		269
Acquisition and divestiture related costs ⁽²⁾	2,846		3,165		8,385		12,919
IT system implementation ⁽³⁾	3,274		1,417		7,743		4,527
Amortization of fair value adjustments ⁽⁴⁾	2,621		793		8,440		793
Acquisition related purchase consideration and post-closing adjustments ⁽⁵⁾	(7,863	)	-		(7,863	)	-
Other	24		-		(83	)	175
Adjusted EBITDA	50,628		48,871		138,063		123,761

Provision for income taxes	(10,530	)	(8,278	)	(19,631	)	(17,695	)
Interest expense and other financing costs	(4,885	)	(5,757	)	(22,784	)	(12,417	)
Depreciation of property, plant, and equipment	(3,589	)	(3,579	)	(14,410	)	(12,153	)
Amortization of intangible assets	(1,547	)	(1,496	)	(5,913	)	(5,095	)
Share-based compensation ⁽⁶⁾	(1,411	)	(1,317	)	(5,458	)	(4,910	)
Tax deduction from vesting of certain share-based awards ⁽⁷⁾	-		-		(1,022	)	(1,399	)
Tax effect of normalization adjustments	(51	)	(1,685	)	(2,761	)	(4,943	)
Adjusted net earnings	28,615		26,759		66,084		65,149


	Three months ended				Twelve months ended
	December 31				December 31
	2023		2022		2023		2022

Gross profit	79,027		71,189		233,559		198,338
Amortization of fair value adjustments	2,621		793		8,440		793
Normalized gross profit	81,648		71,982		241,999		199,131
Normalized gross profit margin	37.1	%	37.3	%	35.8	%	36.4	%

Selling, general and administrative expenses	42,300		32,768		140,304		110,239
Acquisition and divestiture related costs	(2,846	)	(3,165	)	(8,385	)	(12,919	)
IT system implementation	(3,274	)	(1,417	)	(7,743	)	(4,527	)
Other	(24	)	-		83		(175	)
Normalized selling, general and administrative expenses	36,156		28,186		124,259		92,618

Earnings from operations	43,056		37,104		95,250		83,189
Acquisition and divestiture related cost	2,846		3,165		8,385		12,919
IT system implementation	3,274		1,417		7,743		4,527
Amortization of fair value adjustments	2,621		793		8,440		793
Acquisition related purchase consideration and post-closing adjustments ⁽⁵⁾	(7,863	)	-		(7,863	)	-
Other	24		-		(83	)	175
Normalized earnings from operations	43,958		42,479		111,872		101,603
Normalized operating margin	19.9	%	22.0	%	16.5	%	18.6	%

(1)		The Company's share-based compensation expense pertains to its long-term incentive plan ("LTIP" (refer to " Share-based compensation" ), with stock options, performance-based share unit ("PSU"), time-based restricted share unit ("RSU"), and deferred share unit ("DSU") expenses, along with associated payroll taxes.
(2)		Current period expense mainly pertains to legal, consulting and integration costs associated with the acquisition and integration of a former distributor partner in China on April 28, 2023, and the acquisition of youtheory in the U.S. on July 19, 2022.
(3)		Current period expense mainly pertains to development costs associated with IT system implementation to augment the Company's system infrastructure. Unlike other system improvement projects with costs capitalized, due to its cloud-based nature, these system implementation costs are expensed accordingly.
(4)		This cost represents the post-closing amortization of the fair value increase of acquired inventories related to the April 28, 2023 transaction with a former distribution partner in China.
(5)		To adjust for the fair value of purchase consideration accounted for as compensation on the 2022 youtheory acquisition, net of post-acquisition working capital adjustments to reflect acquired liabilities.
(6)		Costs pertaining to LTIP, excluding PSUs granted to certain employees relating to business combinations.
(7)		The vesting of share-based compensation provides a tax benefit during the period in which the awards are settled.

Reconciliation of Net Debt In thousands of Canadian dollars

($ in 000's)	As at December 31,		As at December 31,
	2023		2022

Long-term debt	325,000		400,000
Cash	(36,863	)	(26,240	)
Net debt	288,137		373,760

IDEAYA and Pfizer Expand Clinical Trial Collaboration and Supply Agreement to Evaluate Clinical Combination of IDE196 and Crizotinib in Solid Tumors Harboring GNAQ or GNA11 Mutations

1. Eli Lilly and Company (NYSE:LLY)

2. Novo Nordisk (NYSE:NVO)

3. Johnson & Johnson (NYSE:JNJ)

4. Merck & Company (NYSE:MRK)

5. AbbVie (NYSE:ABBV)

FAQs for pharmaceutical stocks

What does the pharmaceutical industry do?

What is the big pharma business model?

Who are the "Big 3" in pharma?

Which country is number one in the pharma industry?

What are the problems in the pharmaceutical industry?

What is the future of pharmaceuticals?

Are pharmaceutical stocks risky?

Latest News

Latest Press Releases

Related News

TOP STOCKS